Endoscopy

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Introduction

The treatment of benign gallbladder disease has changed substantially in the past decade, but this represents only a snapshot in the evolutionary history of the management of this organ. What began as a problem managed exclusively by open cholecystectomy (CCY) transitioned into a race toward minimally invasive approaches in the 1980s, with advances from gastroenterology, surgery, and radiology.

The opening strides were made in 1980 with the first description of percutaneous cholecystostomy (PC) by Dr. R.W. Radder.¹ Shortly thereafter, in 1984, Dr. Richard Kozarek first reported the feasibility of selective cystic duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP).² Subsequent stenting for the treatment of acute cholecystitis (endoscopic transpapillary gallbladder drainage, ET-GBD) was then reported by Tamada et. al. in 1991.³ Not to be outdone, the first laparoscopic cholecystectomy (LC) was completed by Dr. Med Erich Mühe of Germany in 1985.⁴ More recently, with the expansion of interventional endoscopic ultrasound (EUS), the first transmural EUS-guided gallbladder drainage (EUS-GBD) was described by Dr. Baron and Dr. Topazian in 2007.⁵

Techniques & Tips

ET-GBD

• During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

• After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

• After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

Use of a sphincterotome, which directs toward the patient’s right (most often direction of cystic duct takeoff), is helpful. Angled guidewires are preferable. We often use a 0.035-inch, 260-cm angled hydrophilic wire (GLIDEWIRE; Terumo, Somerset, NJ) to overcome this challenging portion of ET-GBD.

If despite the above maneuvers the guidewire has failed to enter the cystic duct, cholangioscopy can be used to identify the orifice and/or stabilize deep wire cannulation. This is often cumbersome, time consuming, does not always produce success, and requires additional expertise.

• If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
• After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

• This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

• Use of fluoroscopy is optional but can enhance technical success in selected situations.
• Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
• If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

We preferentially use 10-mm diameter by 10-mm saddle length LAMS for EUS-GBD, unless the above distance warrants use of a 15-mm by 15-mm LAMS (AXIOS, Boston Scientific, Marlborough, MA). If the distance is greater than 15 mm, consider searching for an alternative site, using a traditional biliary fully covered self-expandable metal stent (FCSEMS) for longer length, or converting to ET-GBD. Smaller diameter (8 mm) with an 8-mm saddle length can be used as well. The optimal diameter is unknown and also dependent on whether transluminal endoscopic diagnosis or therapy is a consideration.

• If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

If a cholecystostomy tube is in place, instillation of sterile water via the tube can sometimes improve the target for LAMS placement, though caution should be made to not over-distend the gallbladder. ERCP with placement of a nasobiliary tube into the gallbladder can also serve this purpose and has been previously described.¹⁴

The gallbladder can be punctured with a 19-gauge FNA needle to instill sterile water and distend the gallbladder with the added benefit of being able to pass a guidewire, which may enhance procedural safety in difficult cases. However, success of this technique is contingent on fluid remaining within the gallbladder and not transiting out via the cystic duct. Expedient exchange of the FNA needle for the LAMS device may be necessary.

• Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

• Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

• After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
• We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

This exchange can be deferred if the patient is not expected to survive until the one-year anniversary of LAMS deployment. After one year the LAMS plastic covering may degrade and pose additional problems.¹⁵

LAMS Misdeployment Salvage Tips

• Salvage techniques can vary from simple to complex.
• If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
• The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
• If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

• For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
• If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Both ET-GBD and EUS-GBD should be performed by an endoscopist comfortable with their techniques and the management of their adverse events (AEs). Rates for EUS-GBD AEs in patients at high risk for LC were reported in one international multicenter registry to be 15.3% with a 30-day mortality of 9.2%, with a significant predictor of AE being endoscopist experience less than 25 procedures.¹⁶ A meta-analysis also found an overall AE rate of 18.31%, with rates for perforation and stent related AEs (i.e. migration, occlusion, pneumoperitoneum) being 6.71% and 8.16%, respectively.¹⁷ For this reason, we recommend that patients with cholecystitis who are deemed to be poor surgical candidates be transferred to a tertiary referral center with expertise in these approaches. Rates of AEs for ET-GBD are similar to that for standard ERCP, with reported ranges of 5%-10.3%.¹⁰
 

Comparisons Between Techniques

The decision on which technique to utilize for endoscopic management of cholecystitis or symptomatic cholelithiasis depends first and foremost on the expertise and comfort level of the endoscopist. Given the additional training that an advanced endoscopist needs to perform EUS-GBD, combined with the perhaps slightly higher AE rate and permanency of endoscopic cholecystostomy, it is reasonable to proceed with a trial of ET-GBD if confidence is insufficient. However, ET-GBD can certainly be more technically challenging and less effective than EUS-GBD, with lower reported technical and clinical success rates (technical 85.3% vs 93.0%, clinical 95.2% vs 97.3%).¹⁸ Despite this, the rate of recurrence of cholecystitis is similar between ET-GBD and EUS-GBD (4.6% vs 4.2%).¹⁹ As stated above in the Techniques & Tips section, some authors utilize two plastic stents for ET-GBD for this purpose, though with increased technical difficulty. It is important to remember that these numbers, when paired with AE rates, represent the achievements of expert endoscopists.

Discussion with your surgery team is important when deciding modality. If the patient is felt to be a potential candidate for CCY, and EUS-GBD is not being used as a destination therapy, the surgeon may prefer ET-GBD. EUS-GBD may enhance the difficulty of CCY, though at least one study demonstrated that this was no different than PC with similar rates of conversion from LC to open CCY.²⁰ This conversation is most critical for patients who are potential liver transplant candidates. For patients where this is not a consideration there is some evidence to suggest equivalency between LC and EUS-GBD, though certainly EUS-GBD has not yet supplanted LC as the treatment of choice.²¹

While there may eventually be a shift towards EUS-GBD instead of LC in certain patient groups, what is clearer are the advantages of EUS-GBD over PC. One recent meta-analysis revealed that EUS-GBD has significantly favorable odds of overall adverse events (OR 0.43, 95% CI 0.18-1.00), shorter hospital stay (2.76 less days, 95% CI 0.31-5.20 less days), reinterventions (OR 0.15, 95% CI 0.02-0.98), and unplanned readmissions (OR 0.14, 95% CI 0.03-0.70) compared to PC.²² Beyond the data, though, are the emotional and psychological impacts an external drain can have on a patient.
 

Conclusion

When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so. Decision to proceed, especially with EUS-GBD, should be accompanied by conversation and collaboration with surgical teams. If a patient is under consideration for PC instead of LC, it may be worthwhile to seek consultation with a local center with expertise in EUS-GBD or ET-GBD. The adoption of these techniques is part of the paradigm shift, seen broadly throughout medicine, towards minimally invasive interventions, particularly in advanced endoscopy.
 

Dr. Gilman (X @a_gilman) and Dr. Baron (X @EndoTx) are with the University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology. Dr. Gilman has no relevant financial disclosures. Dr. Baron is a consultant and speaker for Ambu, Boston Scientific, Cook Endoscopy, Medtronic, Olympus America, and W.L. Gore.

References

1. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging. 1980;49:330-333.

2. Kozarek RA. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol. 1984;6:37-40.

3. Tamada K et al. Efficacy of endoscopic retrograde cholecystoendoprosthesis (ERCCE) for cholecystitis. Endoscopy. 1991;23:2-3.

4. Reynolds W. The first laparoscopic cholecystectomy. JSLS. 2001;5:89-94.

5. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: Implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. 2007 Apr;65(4):735-7. doi: 10.1016/j.gie.2006.07.041.

6. Irani SS et al. Endoscopic ultrasound-guided transluminal gallbladder drainage in patients with acute cholecystitis: A prospective multicenter trial. Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784.

7. Shen Y et al. Endoscopic ultrasound-guided cholecystostomy for resection of gallbladder polyps with lumen-apposing metal stent. Medicine (Baltimore). 2020 Oct 23;99(43):e22903. doi: 10.1097/MD.0000000000022903.

8. Pang H et al. Endoscopic ultrasound-guided gallbladder endoscopic mucosal resection: A pilot porcine study. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):24-32. doi: 10.1080/13645706.2022.2153228.

9. Imai H et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc. 2016 Jul;84(1):147-51. doi: 10.1016/j.gie.2015.12.024.

10. Saumoy M et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. 2021 Oct;94(4):671-84. doi: 10.1016/j.gie.2021.05.031.

11. Van der Merwe SW et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185-205. doi: 10.1055/a-1717-1391.

12. Storm AC et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-8 e1. doi: 10.1016/j.gie.2021.03.025.

13. James TW, Baron TH. Converting percutaneous gallbladder drainage to internal drainage using EUS-guided therapy: A review of current practices and procedures. Endosc Ultrasound. 2018 Mar-Apr;7(2):93-6. doi: 10.4103/eus.eus_110_17.

14. James TW, Baron TH. Transpapillary nasocystic tube placement to allow gallbladder distention for EUS-guided cholecystoduodenostomy. VideoGIE. 2019 Dec;4(12):561-2. doi: 10.1016/j.vgie.2019.08.009.

15. Gilman AJ, Baron TH. Delamination of a lumen-apposing metal stent with tissue ingrowth and stent-in-stent removal. Gastrointest Endosc. 2023 Sep;98(3):451-3. doi: 10.1016/j.gie.2023.04.2087.

16. Teoh AY et al. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098.

17. Kalva NR et al. Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: A meta-analysis and systematic review. Can J Gastroenterol Hepatol. 2018;2018:7070961. doi: 10.1155/2018/7070961.

18. Khan MA et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87 e3. doi: 10.1016/j.gie.2016.06.032.

19. Mohan BP et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy. 2020 Feb;52(2):96-106. doi: 10.1055/a-1020-3932.

20. Jang JW et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051.

21. Teoh AYB et al. EUS-guided gallbladder drainage versus laparoscopic cholecystectomy for acute cholecystitis: a propensity score analysis with 1-year follow-up data. Gastrointest Endosc. 2021 Mar;93(3):577-83. doi: 10.1016/j.gie.2020.06.066.

22. Luk SW et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-32. doi: 10.1055/a-0929-6603.

Introduction

The treatment of benign gallbladder disease has changed substantially in the past decade, but this represents only a snapshot in the evolutionary history of the management of this organ. What began as a problem managed exclusively by open cholecystectomy (CCY) transitioned into a race toward minimally invasive approaches in the 1980s, with advances from gastroenterology, surgery, and radiology.

The opening strides were made in 1980 with the first description of percutaneous cholecystostomy (PC) by Dr. R.W. Radder.¹ Shortly thereafter, in 1984, Dr. Richard Kozarek first reported the feasibility of selective cystic duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP).² Subsequent stenting for the treatment of acute cholecystitis (endoscopic transpapillary gallbladder drainage, ET-GBD) was then reported by Tamada et. al. in 1991.³ Not to be outdone, the first laparoscopic cholecystectomy (LC) was completed by Dr. Med Erich Mühe of Germany in 1985.⁴ More recently, with the expansion of interventional endoscopic ultrasound (EUS), the first transmural EUS-guided gallbladder drainage (EUS-GBD) was described by Dr. Baron and Dr. Topazian in 2007.⁵

Techniques & Tips

ET-GBD

• During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

• After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

• After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

Use of a sphincterotome, which directs toward the patient’s right (most often direction of cystic duct takeoff), is helpful. Angled guidewires are preferable. We often use a 0.035-inch, 260-cm angled hydrophilic wire (GLIDEWIRE; Terumo, Somerset, NJ) to overcome this challenging portion of ET-GBD.

If despite the above maneuvers the guidewire has failed to enter the cystic duct, cholangioscopy can be used to identify the orifice and/or stabilize deep wire cannulation. This is often cumbersome, time consuming, does not always produce success, and requires additional expertise.

• If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
• After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

• This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

• Use of fluoroscopy is optional but can enhance technical success in selected situations.
• Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
• If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

We preferentially use 10-mm diameter by 10-mm saddle length LAMS for EUS-GBD, unless the above distance warrants use of a 15-mm by 15-mm LAMS (AXIOS, Boston Scientific, Marlborough, MA). If the distance is greater than 15 mm, consider searching for an alternative site, using a traditional biliary fully covered self-expandable metal stent (FCSEMS) for longer length, or converting to ET-GBD. Smaller diameter (8 mm) with an 8-mm saddle length can be used as well. The optimal diameter is unknown and also dependent on whether transluminal endoscopic diagnosis or therapy is a consideration.

• If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

If a cholecystostomy tube is in place, instillation of sterile water via the tube can sometimes improve the target for LAMS placement, though caution should be made to not over-distend the gallbladder. ERCP with placement of a nasobiliary tube into the gallbladder can also serve this purpose and has been previously described.¹⁴

The gallbladder can be punctured with a 19-gauge FNA needle to instill sterile water and distend the gallbladder with the added benefit of being able to pass a guidewire, which may enhance procedural safety in difficult cases. However, success of this technique is contingent on fluid remaining within the gallbladder and not transiting out via the cystic duct. Expedient exchange of the FNA needle for the LAMS device may be necessary.

• Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

• Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

• After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
• We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

This exchange can be deferred if the patient is not expected to survive until the one-year anniversary of LAMS deployment. After one year the LAMS plastic covering may degrade and pose additional problems.¹⁵

LAMS Misdeployment Salvage Tips

• Salvage techniques can vary from simple to complex.
• If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
• The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
• If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

• For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
• If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Both ET-GBD and EUS-GBD should be performed by an endoscopist comfortable with their techniques and the management of their adverse events (AEs). Rates for EUS-GBD AEs in patients at high risk for LC were reported in one international multicenter registry to be 15.3% with a 30-day mortality of 9.2%, with a significant predictor of AE being endoscopist experience less than 25 procedures.¹⁶ A meta-analysis also found an overall AE rate of 18.31%, with rates for perforation and stent related AEs (i.e. migration, occlusion, pneumoperitoneum) being 6.71% and 8.16%, respectively.¹⁷ For this reason, we recommend that patients with cholecystitis who are deemed to be poor surgical candidates be transferred to a tertiary referral center with expertise in these approaches. Rates of AEs for ET-GBD are similar to that for standard ERCP, with reported ranges of 5%-10.3%.¹⁰
 

Comparisons Between Techniques

The decision on which technique to utilize for endoscopic management of cholecystitis or symptomatic cholelithiasis depends first and foremost on the expertise and comfort level of the endoscopist. Given the additional training that an advanced endoscopist needs to perform EUS-GBD, combined with the perhaps slightly higher AE rate and permanency of endoscopic cholecystostomy, it is reasonable to proceed with a trial of ET-GBD if confidence is insufficient. However, ET-GBD can certainly be more technically challenging and less effective than EUS-GBD, with lower reported technical and clinical success rates (technical 85.3% vs 93.0%, clinical 95.2% vs 97.3%).¹⁸ Despite this, the rate of recurrence of cholecystitis is similar between ET-GBD and EUS-GBD (4.6% vs 4.2%).¹⁹ As stated above in the Techniques & Tips section, some authors utilize two plastic stents for ET-GBD for this purpose, though with increased technical difficulty. It is important to remember that these numbers, when paired with AE rates, represent the achievements of expert endoscopists.

Discussion with your surgery team is important when deciding modality. If the patient is felt to be a potential candidate for CCY, and EUS-GBD is not being used as a destination therapy, the surgeon may prefer ET-GBD. EUS-GBD may enhance the difficulty of CCY, though at least one study demonstrated that this was no different than PC with similar rates of conversion from LC to open CCY.²⁰ This conversation is most critical for patients who are potential liver transplant candidates. For patients where this is not a consideration there is some evidence to suggest equivalency between LC and EUS-GBD, though certainly EUS-GBD has not yet supplanted LC as the treatment of choice.²¹

While there may eventually be a shift towards EUS-GBD instead of LC in certain patient groups, what is clearer are the advantages of EUS-GBD over PC. One recent meta-analysis revealed that EUS-GBD has significantly favorable odds of overall adverse events (OR 0.43, 95% CI 0.18-1.00), shorter hospital stay (2.76 less days, 95% CI 0.31-5.20 less days), reinterventions (OR 0.15, 95% CI 0.02-0.98), and unplanned readmissions (OR 0.14, 95% CI 0.03-0.70) compared to PC.²² Beyond the data, though, are the emotional and psychological impacts an external drain can have on a patient.
 

Conclusion

When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so. Decision to proceed, especially with EUS-GBD, should be accompanied by conversation and collaboration with surgical teams. If a patient is under consideration for PC instead of LC, it may be worthwhile to seek consultation with a local center with expertise in EUS-GBD or ET-GBD. The adoption of these techniques is part of the paradigm shift, seen broadly throughout medicine, towards minimally invasive interventions, particularly in advanced endoscopy.
 

Dr. Gilman (X @a_gilman) and Dr. Baron (X @EndoTx) are with the University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology. Dr. Gilman has no relevant financial disclosures. Dr. Baron is a consultant and speaker for Ambu, Boston Scientific, Cook Endoscopy, Medtronic, Olympus America, and W.L. Gore.

References

1. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging. 1980;49:330-333.

2. Kozarek RA. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol. 1984;6:37-40.

3. Tamada K et al. Efficacy of endoscopic retrograde cholecystoendoprosthesis (ERCCE) for cholecystitis. Endoscopy. 1991;23:2-3.

4. Reynolds W. The first laparoscopic cholecystectomy. JSLS. 2001;5:89-94.

5. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: Implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. 2007 Apr;65(4):735-7. doi: 10.1016/j.gie.2006.07.041.

6. Irani SS et al. Endoscopic ultrasound-guided transluminal gallbladder drainage in patients with acute cholecystitis: A prospective multicenter trial. Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784.

7. Shen Y et al. Endoscopic ultrasound-guided cholecystostomy for resection of gallbladder polyps with lumen-apposing metal stent. Medicine (Baltimore). 2020 Oct 23;99(43):e22903. doi: 10.1097/MD.0000000000022903.

8. Pang H et al. Endoscopic ultrasound-guided gallbladder endoscopic mucosal resection: A pilot porcine study. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):24-32. doi: 10.1080/13645706.2022.2153228.

9. Imai H et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc. 2016 Jul;84(1):147-51. doi: 10.1016/j.gie.2015.12.024.

10. Saumoy M et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. 2021 Oct;94(4):671-84. doi: 10.1016/j.gie.2021.05.031.

11. Van der Merwe SW et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185-205. doi: 10.1055/a-1717-1391.

12. Storm AC et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-8 e1. doi: 10.1016/j.gie.2021.03.025.

13. James TW, Baron TH. Converting percutaneous gallbladder drainage to internal drainage using EUS-guided therapy: A review of current practices and procedures. Endosc Ultrasound. 2018 Mar-Apr;7(2):93-6. doi: 10.4103/eus.eus_110_17.

14. James TW, Baron TH. Transpapillary nasocystic tube placement to allow gallbladder distention for EUS-guided cholecystoduodenostomy. VideoGIE. 2019 Dec;4(12):561-2. doi: 10.1016/j.vgie.2019.08.009.

15. Gilman AJ, Baron TH. Delamination of a lumen-apposing metal stent with tissue ingrowth and stent-in-stent removal. Gastrointest Endosc. 2023 Sep;98(3):451-3. doi: 10.1016/j.gie.2023.04.2087.

16. Teoh AY et al. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098.

17. Kalva NR et al. Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: A meta-analysis and systematic review. Can J Gastroenterol Hepatol. 2018;2018:7070961. doi: 10.1155/2018/7070961.

18. Khan MA et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87 e3. doi: 10.1016/j.gie.2016.06.032.

19. Mohan BP et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy. 2020 Feb;52(2):96-106. doi: 10.1055/a-1020-3932.

20. Jang JW et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051.

21. Teoh AYB et al. EUS-guided gallbladder drainage versus laparoscopic cholecystectomy for acute cholecystitis: a propensity score analysis with 1-year follow-up data. Gastrointest Endosc. 2021 Mar;93(3):577-83. doi: 10.1016/j.gie.2020.06.066.

22. Luk SW et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-32. doi: 10.1055/a-0929-6603.

Introduction

The treatment of benign gallbladder disease has changed substantially in the past decade, but this represents only a snapshot in the evolutionary history of the management of this organ. What began as a problem managed exclusively by open cholecystectomy (CCY) transitioned into a race toward minimally invasive approaches in the 1980s, with advances from gastroenterology, surgery, and radiology.

The opening strides were made in 1980 with the first description of percutaneous cholecystostomy (PC) by Dr. R.W. Radder.¹ Shortly thereafter, in 1984, Dr. Richard Kozarek first reported the feasibility of selective cystic duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP).² Subsequent stenting for the treatment of acute cholecystitis (endoscopic transpapillary gallbladder drainage, ET-GBD) was then reported by Tamada et. al. in 1991.³ Not to be outdone, the first laparoscopic cholecystectomy (LC) was completed by Dr. Med Erich Mühe of Germany in 1985.⁴ More recently, with the expansion of interventional endoscopic ultrasound (EUS), the first transmural EUS-guided gallbladder drainage (EUS-GBD) was described by Dr. Baron and Dr. Topazian in 2007.⁵

Techniques & Tips

ET-GBD

• During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

• After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

• After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

Use of a sphincterotome, which directs toward the patient’s right (most often direction of cystic duct takeoff), is helpful. Angled guidewires are preferable. We often use a 0.035-inch, 260-cm angled hydrophilic wire (GLIDEWIRE; Terumo, Somerset, NJ) to overcome this challenging portion of ET-GBD.

If despite the above maneuvers the guidewire has failed to enter the cystic duct, cholangioscopy can be used to identify the orifice and/or stabilize deep wire cannulation. This is often cumbersome, time consuming, does not always produce success, and requires additional expertise.

• If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
• After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

• This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

• Use of fluoroscopy is optional but can enhance technical success in selected situations.
• Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
• If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

We preferentially use 10-mm diameter by 10-mm saddle length LAMS for EUS-GBD, unless the above distance warrants use of a 15-mm by 15-mm LAMS (AXIOS, Boston Scientific, Marlborough, MA). If the distance is greater than 15 mm, consider searching for an alternative site, using a traditional biliary fully covered self-expandable metal stent (FCSEMS) for longer length, or converting to ET-GBD. Smaller diameter (8 mm) with an 8-mm saddle length can be used as well. The optimal diameter is unknown and also dependent on whether transluminal endoscopic diagnosis or therapy is a consideration.

• If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

If a cholecystostomy tube is in place, instillation of sterile water via the tube can sometimes improve the target for LAMS placement, though caution should be made to not over-distend the gallbladder. ERCP with placement of a nasobiliary tube into the gallbladder can also serve this purpose and has been previously described.¹⁴

The gallbladder can be punctured with a 19-gauge FNA needle to instill sterile water and distend the gallbladder with the added benefit of being able to pass a guidewire, which may enhance procedural safety in difficult cases. However, success of this technique is contingent on fluid remaining within the gallbladder and not transiting out via the cystic duct. Expedient exchange of the FNA needle for the LAMS device may be necessary.

• Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

• Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

• After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
• We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

This exchange can be deferred if the patient is not expected to survive until the one-year anniversary of LAMS deployment. After one year the LAMS plastic covering may degrade and pose additional problems.¹⁵

LAMS Misdeployment Salvage Tips

• Salvage techniques can vary from simple to complex.
• If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
• The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
• If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

• For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
• If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Both ET-GBD and EUS-GBD should be performed by an endoscopist comfortable with their techniques and the management of their adverse events (AEs). Rates for EUS-GBD AEs in patients at high risk for LC were reported in one international multicenter registry to be 15.3% with a 30-day mortality of 9.2%, with a significant predictor of AE being endoscopist experience less than 25 procedures.¹⁶ A meta-analysis also found an overall AE rate of 18.31%, with rates for perforation and stent related AEs (i.e. migration, occlusion, pneumoperitoneum) being 6.71% and 8.16%, respectively.¹⁷ For this reason, we recommend that patients with cholecystitis who are deemed to be poor surgical candidates be transferred to a tertiary referral center with expertise in these approaches. Rates of AEs for ET-GBD are similar to that for standard ERCP, with reported ranges of 5%-10.3%.¹⁰
 

Comparisons Between Techniques

The decision on which technique to utilize for endoscopic management of cholecystitis or symptomatic cholelithiasis depends first and foremost on the expertise and comfort level of the endoscopist. Given the additional training that an advanced endoscopist needs to perform EUS-GBD, combined with the perhaps slightly higher AE rate and permanency of endoscopic cholecystostomy, it is reasonable to proceed with a trial of ET-GBD if confidence is insufficient. However, ET-GBD can certainly be more technically challenging and less effective than EUS-GBD, with lower reported technical and clinical success rates (technical 85.3% vs 93.0%, clinical 95.2% vs 97.3%).¹⁸ Despite this, the rate of recurrence of cholecystitis is similar between ET-GBD and EUS-GBD (4.6% vs 4.2%).¹⁹ As stated above in the Techniques & Tips section, some authors utilize two plastic stents for ET-GBD for this purpose, though with increased technical difficulty. It is important to remember that these numbers, when paired with AE rates, represent the achievements of expert endoscopists.

Discussion with your surgery team is important when deciding modality. If the patient is felt to be a potential candidate for CCY, and EUS-GBD is not being used as a destination therapy, the surgeon may prefer ET-GBD. EUS-GBD may enhance the difficulty of CCY, though at least one study demonstrated that this was no different than PC with similar rates of conversion from LC to open CCY.²⁰ This conversation is most critical for patients who are potential liver transplant candidates. For patients where this is not a consideration there is some evidence to suggest equivalency between LC and EUS-GBD, though certainly EUS-GBD has not yet supplanted LC as the treatment of choice.²¹

While there may eventually be a shift towards EUS-GBD instead of LC in certain patient groups, what is clearer are the advantages of EUS-GBD over PC. One recent meta-analysis revealed that EUS-GBD has significantly favorable odds of overall adverse events (OR 0.43, 95% CI 0.18-1.00), shorter hospital stay (2.76 less days, 95% CI 0.31-5.20 less days), reinterventions (OR 0.15, 95% CI 0.02-0.98), and unplanned readmissions (OR 0.14, 95% CI 0.03-0.70) compared to PC.²² Beyond the data, though, are the emotional and psychological impacts an external drain can have on a patient.
 

Conclusion

When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so. Decision to proceed, especially with EUS-GBD, should be accompanied by conversation and collaboration with surgical teams. If a patient is under consideration for PC instead of LC, it may be worthwhile to seek consultation with a local center with expertise in EUS-GBD or ET-GBD. The adoption of these techniques is part of the paradigm shift, seen broadly throughout medicine, towards minimally invasive interventions, particularly in advanced endoscopy.
 

Dr. Gilman (X @a_gilman) and Dr. Baron (X @EndoTx) are with the University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology. Dr. Gilman has no relevant financial disclosures. Dr. Baron is a consultant and speaker for Ambu, Boston Scientific, Cook Endoscopy, Medtronic, Olympus America, and W.L. Gore.

References

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3. Tamada K et al. Efficacy of endoscopic retrograde cholecystoendoprosthesis (ERCCE) for cholecystitis. Endoscopy. 1991;23:2-3.

4. Reynolds W. The first laparoscopic cholecystectomy. JSLS. 2001;5:89-94.

5. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: Implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. 2007 Apr;65(4):735-7. doi: 10.1016/j.gie.2006.07.041.

6. Irani SS et al. Endoscopic ultrasound-guided transluminal gallbladder drainage in patients with acute cholecystitis: A prospective multicenter trial. Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784.

7. Shen Y et al. Endoscopic ultrasound-guided cholecystostomy for resection of gallbladder polyps with lumen-apposing metal stent. Medicine (Baltimore). 2020 Oct 23;99(43):e22903. doi: 10.1097/MD.0000000000022903.

8. Pang H et al. Endoscopic ultrasound-guided gallbladder endoscopic mucosal resection: A pilot porcine study. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):24-32. doi: 10.1080/13645706.2022.2153228.

9. Imai H et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc. 2016 Jul;84(1):147-51. doi: 10.1016/j.gie.2015.12.024.

10. Saumoy M et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. 2021 Oct;94(4):671-84. doi: 10.1016/j.gie.2021.05.031.

11. Van der Merwe SW et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185-205. doi: 10.1055/a-1717-1391.

12. Storm AC et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-8 e1. doi: 10.1016/j.gie.2021.03.025.

13. James TW, Baron TH. Converting percutaneous gallbladder drainage to internal drainage using EUS-guided therapy: A review of current practices and procedures. Endosc Ultrasound. 2018 Mar-Apr;7(2):93-6. doi: 10.4103/eus.eus_110_17.

14. James TW, Baron TH. Transpapillary nasocystic tube placement to allow gallbladder distention for EUS-guided cholecystoduodenostomy. VideoGIE. 2019 Dec;4(12):561-2. doi: 10.1016/j.vgie.2019.08.009.

15. Gilman AJ, Baron TH. Delamination of a lumen-apposing metal stent with tissue ingrowth and stent-in-stent removal. Gastrointest Endosc. 2023 Sep;98(3):451-3. doi: 10.1016/j.gie.2023.04.2087.

16. Teoh AY et al. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098.

17. Kalva NR et al. Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: A meta-analysis and systematic review. Can J Gastroenterol Hepatol. 2018;2018:7070961. doi: 10.1155/2018/7070961.

18. Khan MA et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87 e3. doi: 10.1016/j.gie.2016.06.032.

19. Mohan BP et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy. 2020 Feb;52(2):96-106. doi: 10.1055/a-1020-3932.

20. Jang JW et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051.

21. Teoh AYB et al. EUS-guided gallbladder drainage versus laparoscopic cholecystectomy for acute cholecystitis: a propensity score analysis with 1-year follow-up data. Gastrointest Endosc. 2021 Mar;93(3):577-83. doi: 10.1016/j.gie.2020.06.066.

22. Luk SW et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-32. doi: 10.1055/a-0929-6603.

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

Artificial intelligence (AI) systems show high potential for detecting mucosal healing in ulcerative colitis with optimal diagnostic performance, according to a new systematic review and meta-analysis.

AI algorithms replicated expert opinion with high sensitivity and specificity when evaluating images and videos. At the same time, moderate-high heterogeneity of the data was found, the authors noted.

“Artificial intelligence software is expected to potentially solve the longstanding issue of low-to-moderate interobserver agreement when human endoscopists are required to indicate mucosal healing or different grades of inflammation in ulcerative colitis,” Alessandro Rimondi, lead author and clinical fellow at the Royal Free Hospital and University College London Institute for Liver and Digestive Health, London, England, told this news organization.

“However, high levels of heterogeneity have been found, potentially linked to how differently the AI software was trained and how many cases it has been tested on,” he said. “This partially limits the quality of the body of evidence.”

The study was published online in Digestive and Liver Disease.
 

Evaluating AI Detection

In clinical practice, assessing mucosal healing in inflammatory bowel disease (IBD) is critical for evaluating a patient’s response to therapy and guiding strategies for treatment, surgery, and endoscopic surveillance. In an era of precision medicine, assessment of mucosal healing should be precise, readily available in an endoscopic report, and highly reproducible, which requires high accuracy and agreement in endoscopic diagnosis, the authors noted.

AI systems — particularly deep learning algorithms based on convolutional neural network architecture — may allow endoscopists to establish an objective and real-time diagnosis of mucosal healing and improve the average quality standards at primary and tertiary care centers, the authors wrote. Research on AI in IBD has looked at potential implications for endoscopy and clinical management, which opens new areas to explore.

Dr. Rimondi and colleagues conducted a systematic review of studies up to December 2022 that involved an AI-based system used to estimate any degree of endoscopic inflammation in IBD, whether ulcerative colitis or Crohn’s disease. After that, they conducted a diagnostic test accuracy meta-analysis restricted to the field in which more than five studies providing diagnostic performance — mucosal healing in ulcerative colitis based on luminal imaging — were available.

The researchers identified 12 studies with luminal imaging in patients with ulcerative colitis. Four evaluated the performance of AI systems on videos, six focused on fixed images, and two looked at both.

Overall, the AI systems achieved a satisfactory performance in evaluating mucosal healing in ulcerative colitis. When evaluating fixed images, the algorithms achieved a sensitivity of 0.91 and specificity of 0.89, with a diagnostic odds ratio (DOR) of 92.42, summary receiver operating characteristic curve (SROC) of 0.957, and area under the curve (AUC) of 0.957. When evaluating videos, the algorithms achieved 0.86 sensitivity, 0.91 specificity, 70.86 DOR, 0.941 SROC, and 0.941 AUC.

“It is exciting to see artificial intelligence expand and be effective for conditions beyond colon polyps,” Seth Gross, MD, professor of medicine and clinical chief of gastroenterology and hepatology at NYU Langone Health, New York, told this news organization.

Dr. Gross, who wasn’t involved with this study, has researched AI applications in endoscopy and colonoscopy. He and colleagues have found that machine learning software can improve lesion and polyp detection, serving as a “second set of eyes” for practitioners.

“Mucosal healing interpretation can be variable amongst providers,” he said. “AI has the potential to help standardize the assessment of mucosal healing in patients with ulcerative colitis.”
 

Improving AI Training

The authors found moderate-high levels of heterogeneity among the studies, which limited the quality of the evidence. Only 2 of the 12 studies used an external dataset to validate the AI systems, and 1 evaluated the AI system on a mixed database. However, seven used an internal validation dataset separate from the training dataset.

It is crucial to find a shared consensus on training for AI models, with a shared definition of mucosal healing and cutoff thresholds based on recent guidelines, Dr. Rimondi and colleagues noted. Training data ideally should be on the basis of a broad and shared database containing images and videos with high interobserver agreement on the degree of inflammation, they added.

“We probably need a consensus or guidelines that identify the standards for training and testing newly developed software, stating the bare minimum number of images or videos for the training and testing sections,” Dr. Rimondi said.

In addition, due to interobserver misalignment, an expert-validated database could help serve the purpose of a gold standard, he added.

“In my opinion, artificial intelligence tends to better perform when it is required to evaluate a dichotomic outcome (such as polyp detection, which is a yes or no task) than when it is required to replicate more difficult tasks (such as polyp characterization or judging a degree of inflammation), which have a continuous range of expression,” Dr. Rimondi said.

The authors declared no financial support for this study. Dr. Rimondi and Dr. Gross reported no financial disclosures.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) systems show high potential for detecting mucosal healing in ulcerative colitis with optimal diagnostic performance, according to a new systematic review and meta-analysis.

AI algorithms replicated expert opinion with high sensitivity and specificity when evaluating images and videos. At the same time, moderate-high heterogeneity of the data was found, the authors noted.

“Artificial intelligence software is expected to potentially solve the longstanding issue of low-to-moderate interobserver agreement when human endoscopists are required to indicate mucosal healing or different grades of inflammation in ulcerative colitis,” Alessandro Rimondi, lead author and clinical fellow at the Royal Free Hospital and University College London Institute for Liver and Digestive Health, London, England, told this news organization.

“However, high levels of heterogeneity have been found, potentially linked to how differently the AI software was trained and how many cases it has been tested on,” he said. “This partially limits the quality of the body of evidence.”

The study was published online in Digestive and Liver Disease.
 

Evaluating AI Detection

In clinical practice, assessing mucosal healing in inflammatory bowel disease (IBD) is critical for evaluating a patient’s response to therapy and guiding strategies for treatment, surgery, and endoscopic surveillance. In an era of precision medicine, assessment of mucosal healing should be precise, readily available in an endoscopic report, and highly reproducible, which requires high accuracy and agreement in endoscopic diagnosis, the authors noted.

AI systems — particularly deep learning algorithms based on convolutional neural network architecture — may allow endoscopists to establish an objective and real-time diagnosis of mucosal healing and improve the average quality standards at primary and tertiary care centers, the authors wrote. Research on AI in IBD has looked at potential implications for endoscopy and clinical management, which opens new areas to explore.

Dr. Rimondi and colleagues conducted a systematic review of studies up to December 2022 that involved an AI-based system used to estimate any degree of endoscopic inflammation in IBD, whether ulcerative colitis or Crohn’s disease. After that, they conducted a diagnostic test accuracy meta-analysis restricted to the field in which more than five studies providing diagnostic performance — mucosal healing in ulcerative colitis based on luminal imaging — were available.

The researchers identified 12 studies with luminal imaging in patients with ulcerative colitis. Four evaluated the performance of AI systems on videos, six focused on fixed images, and two looked at both.

Overall, the AI systems achieved a satisfactory performance in evaluating mucosal healing in ulcerative colitis. When evaluating fixed images, the algorithms achieved a sensitivity of 0.91 and specificity of 0.89, with a diagnostic odds ratio (DOR) of 92.42, summary receiver operating characteristic curve (SROC) of 0.957, and area under the curve (AUC) of 0.957. When evaluating videos, the algorithms achieved 0.86 sensitivity, 0.91 specificity, 70.86 DOR, 0.941 SROC, and 0.941 AUC.

“It is exciting to see artificial intelligence expand and be effective for conditions beyond colon polyps,” Seth Gross, MD, professor of medicine and clinical chief of gastroenterology and hepatology at NYU Langone Health, New York, told this news organization.

Dr. Gross, who wasn’t involved with this study, has researched AI applications in endoscopy and colonoscopy. He and colleagues have found that machine learning software can improve lesion and polyp detection, serving as a “second set of eyes” for practitioners.

“Mucosal healing interpretation can be variable amongst providers,” he said. “AI has the potential to help standardize the assessment of mucosal healing in patients with ulcerative colitis.”
 

Improving AI Training

The authors found moderate-high levels of heterogeneity among the studies, which limited the quality of the evidence. Only 2 of the 12 studies used an external dataset to validate the AI systems, and 1 evaluated the AI system on a mixed database. However, seven used an internal validation dataset separate from the training dataset.

It is crucial to find a shared consensus on training for AI models, with a shared definition of mucosal healing and cutoff thresholds based on recent guidelines, Dr. Rimondi and colleagues noted. Training data ideally should be on the basis of a broad and shared database containing images and videos with high interobserver agreement on the degree of inflammation, they added.

“We probably need a consensus or guidelines that identify the standards for training and testing newly developed software, stating the bare minimum number of images or videos for the training and testing sections,” Dr. Rimondi said.

In addition, due to interobserver misalignment, an expert-validated database could help serve the purpose of a gold standard, he added.

“In my opinion, artificial intelligence tends to better perform when it is required to evaluate a dichotomic outcome (such as polyp detection, which is a yes or no task) than when it is required to replicate more difficult tasks (such as polyp characterization or judging a degree of inflammation), which have a continuous range of expression,” Dr. Rimondi said.

The authors declared no financial support for this study. Dr. Rimondi and Dr. Gross reported no financial disclosures.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) systems show high potential for detecting mucosal healing in ulcerative colitis with optimal diagnostic performance, according to a new systematic review and meta-analysis.

AI algorithms replicated expert opinion with high sensitivity and specificity when evaluating images and videos. At the same time, moderate-high heterogeneity of the data was found, the authors noted.

“Artificial intelligence software is expected to potentially solve the longstanding issue of low-to-moderate interobserver agreement when human endoscopists are required to indicate mucosal healing or different grades of inflammation in ulcerative colitis,” Alessandro Rimondi, lead author and clinical fellow at the Royal Free Hospital and University College London Institute for Liver and Digestive Health, London, England, told this news organization.

“However, high levels of heterogeneity have been found, potentially linked to how differently the AI software was trained and how many cases it has been tested on,” he said. “This partially limits the quality of the body of evidence.”

The study was published online in Digestive and Liver Disease.
 

Evaluating AI Detection

In clinical practice, assessing mucosal healing in inflammatory bowel disease (IBD) is critical for evaluating a patient’s response to therapy and guiding strategies for treatment, surgery, and endoscopic surveillance. In an era of precision medicine, assessment of mucosal healing should be precise, readily available in an endoscopic report, and highly reproducible, which requires high accuracy and agreement in endoscopic diagnosis, the authors noted.

AI systems — particularly deep learning algorithms based on convolutional neural network architecture — may allow endoscopists to establish an objective and real-time diagnosis of mucosal healing and improve the average quality standards at primary and tertiary care centers, the authors wrote. Research on AI in IBD has looked at potential implications for endoscopy and clinical management, which opens new areas to explore.

Dr. Rimondi and colleagues conducted a systematic review of studies up to December 2022 that involved an AI-based system used to estimate any degree of endoscopic inflammation in IBD, whether ulcerative colitis or Crohn’s disease. After that, they conducted a diagnostic test accuracy meta-analysis restricted to the field in which more than five studies providing diagnostic performance — mucosal healing in ulcerative colitis based on luminal imaging — were available.

The researchers identified 12 studies with luminal imaging in patients with ulcerative colitis. Four evaluated the performance of AI systems on videos, six focused on fixed images, and two looked at both.

Overall, the AI systems achieved a satisfactory performance in evaluating mucosal healing in ulcerative colitis. When evaluating fixed images, the algorithms achieved a sensitivity of 0.91 and specificity of 0.89, with a diagnostic odds ratio (DOR) of 92.42, summary receiver operating characteristic curve (SROC) of 0.957, and area under the curve (AUC) of 0.957. When evaluating videos, the algorithms achieved 0.86 sensitivity, 0.91 specificity, 70.86 DOR, 0.941 SROC, and 0.941 AUC.

“It is exciting to see artificial intelligence expand and be effective for conditions beyond colon polyps,” Seth Gross, MD, professor of medicine and clinical chief of gastroenterology and hepatology at NYU Langone Health, New York, told this news organization.

Dr. Gross, who wasn’t involved with this study, has researched AI applications in endoscopy and colonoscopy. He and colleagues have found that machine learning software can improve lesion and polyp detection, serving as a “second set of eyes” for practitioners.

“Mucosal healing interpretation can be variable amongst providers,” he said. “AI has the potential to help standardize the assessment of mucosal healing in patients with ulcerative colitis.”
 

Improving AI Training

The authors found moderate-high levels of heterogeneity among the studies, which limited the quality of the evidence. Only 2 of the 12 studies used an external dataset to validate the AI systems, and 1 evaluated the AI system on a mixed database. However, seven used an internal validation dataset separate from the training dataset.

It is crucial to find a shared consensus on training for AI models, with a shared definition of mucosal healing and cutoff thresholds based on recent guidelines, Dr. Rimondi and colleagues noted. Training data ideally should be on the basis of a broad and shared database containing images and videos with high interobserver agreement on the degree of inflammation, they added.

“We probably need a consensus or guidelines that identify the standards for training and testing newly developed software, stating the bare minimum number of images or videos for the training and testing sections,” Dr. Rimondi said.

In addition, due to interobserver misalignment, an expert-validated database could help serve the purpose of a gold standard, he added.

“In my opinion, artificial intelligence tends to better perform when it is required to evaluate a dichotomic outcome (such as polyp detection, which is a yes or no task) than when it is required to replicate more difficult tasks (such as polyp characterization or judging a degree of inflammation), which have a continuous range of expression,” Dr. Rimondi said.

The authors declared no financial support for this study. Dr. Rimondi and Dr. Gross reported no financial disclosures.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Two novel devices are similarly effective for tissue approximation of large endoscopic resection defects, but each has advantages, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

“We know from previous data that defect closure is beneficial, and reduces complications such as delayed bleeding and delayed perforation,” said Salmaan A. Jawaid, MD, of Baylor College of Medicine, Houston, in a presentation at the meeting.

Baylor College of Medicine

In the past, defect closure was relatively straightforward; however, “the characteristics of these defects are evolving,” and defects are increasing in size, complexity, and number of locations, he said.

In response, management of resection defects has shifted from a one-step closure to a two-step process with approximation of the widest mucosal edges first, followed by complete resection bed closure, Dr. Jawaid said.

Two novel through the scope (TTS) tissue approximation devices used for the closure of large endoscopic resection defects – the dual-action tissue clip (DAT) and the TTS tack/suture device (TSD) – have not been directly compared on the basis of efficacy and cost, he said.

In the current study, Dr. Jawaid and colleagues randomized 56 adults undergoing tissue approximation and defect closure after endoscopic resection to DAT (31 patients) or TSD (25 patients). The patients were treated at a single center between August 2022 and May 2023 for closures of endoscopic resection defects including gastric, duodenum, and colon lesions greater than 20 mm wide and greater than 30 mm long.

The primary outcomes were technical success of tissue approximation and tissue approximation costs. Secondary outcomes were technical success of complete closure, closure costs, and speed of approximation and closure, as well as safety outcomes. Tissue approximation was defined as less than 15 mm of visible resection bed at the widest margin, and complete closure was defined as no visible resection bed.

Tissue approximation rates were not significantly different between the TSD and DAT groups (88% vs. 83.9%, P = .92). However, approximation cost was significantly lower for DAT compared to TSD ($673.1 vs. $973.6; P = .002).

Similarly, complete closure rates were not significantly different between the TSD and DAT groups (92% vs. 93.5%, P = .83), but closure cost/mm² was significantly lower for DAT compared to TSD ($1.0/mm² vs. $1.6/mm²; P = .002).

Notably, the three DAT failures (60%) underwent successful tissue approximation with TSD, and the single TSD failure (33%) underwent successful tissue approximation using DAT.

In terms of speed, the averages for both tissue approximation time and closure speed were significantly faster in the DAT group, compared with the TSD group (12.2 minutes vs. 4 minutes, P < .0001; 72.7 mm²/min vs. 153.5 mm²/min; P = .003).

“The DAT clip was three times faster than the TSD,” Dr. Jawaid said in his presentation. Adverse events including device-related events, post–electrocautery syndrome, and delayed bleeding were similarly low with both devices. However, the DAT can be less effective in some circumstances, such as a closed space or difficult location. In the cases of duodenal defects, TSD was able to approximate all, but DAT was unable to approximate any. Reasons for DAT clip failure in these cases included the resection bed being too large and tissue tearing upon grasping. In the TSD group, the presence of looping was associated with failures for cecum and colon defects.
 

Data may inform device decisions

“This was an important study conducted to evaluate the different scope devices for defect closure,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and is executive vice chair of internal medicine at the University of Cincinnati.

“These devices have an impact on risk for delayed bleeding and perforation,” said Dr. Afzali, who served as moderator of the session in which the study was presented.

“With different items now available for defect closure, this randomized controlled study provides guidance on which TTS approximation device should be considered, and help determine effectiveness of defect closure,” she said.

“The results of this randomized controlled trial were very informative,” Dr. Afzali said. The data indicated that both DAT and TSD achieved similar rates of tissue approximation and complete closure, but “what was interesting was that one TSD is equivalent to two DAT for tissue approximation. Further, tissue approximation was three times faster with DAT, and complete closure costs were lower in the DAT-treated group.”

In clinical practice, “the study was able to help identify scenarios, such as resection beds involving greater than 50% circumference or defects located in the duodenum, where TSD is preferred over DAT for defect closure. These suggested scenarios are also important for clinical practice and device considerations,” Dr. Afzali said. “Additional studies with use of both devices, TSD and DAT simultaneously on a defect site may be needed to further assist endoscopists in defect management.”

The study was limited by the small size and use of data from a single center.

However, “based on our interim data, both devices are equally effective for tissue approximation of large endoscopic defects,” and facilitate complete defect closure, Dr. Jawaid said.

Ultimately, “both devices have a role,” with DAT being faster and likely more cost effective, while TSD is likely preferable for defects in the duodenum and those with a circumference greater than 50%, he said.

The study received no outside funding. Dr. Jawaid disclosed a consultancy with Boston Scientific, ConMed, CREO Speedboat, and DiLumen. Dr. Afzali disclosed numerous relationships with pharma including having served as an advisor/consultant for AbbVie, Bristol Myers Squibb/Celgene, Eli Lilly, and Gilead, among others.

Two novel devices are similarly effective for tissue approximation of large endoscopic resection defects, but each has advantages, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

“We know from previous data that defect closure is beneficial, and reduces complications such as delayed bleeding and delayed perforation,” said Salmaan A. Jawaid, MD, of Baylor College of Medicine, Houston, in a presentation at the meeting.

Baylor College of Medicine

In the past, defect closure was relatively straightforward; however, “the characteristics of these defects are evolving,” and defects are increasing in size, complexity, and number of locations, he said.

In response, management of resection defects has shifted from a one-step closure to a two-step process with approximation of the widest mucosal edges first, followed by complete resection bed closure, Dr. Jawaid said.

Two novel through the scope (TTS) tissue approximation devices used for the closure of large endoscopic resection defects – the dual-action tissue clip (DAT) and the TTS tack/suture device (TSD) – have not been directly compared on the basis of efficacy and cost, he said.

In the current study, Dr. Jawaid and colleagues randomized 56 adults undergoing tissue approximation and defect closure after endoscopic resection to DAT (31 patients) or TSD (25 patients). The patients were treated at a single center between August 2022 and May 2023 for closures of endoscopic resection defects including gastric, duodenum, and colon lesions greater than 20 mm wide and greater than 30 mm long.

The primary outcomes were technical success of tissue approximation and tissue approximation costs. Secondary outcomes were technical success of complete closure, closure costs, and speed of approximation and closure, as well as safety outcomes. Tissue approximation was defined as less than 15 mm of visible resection bed at the widest margin, and complete closure was defined as no visible resection bed.

Tissue approximation rates were not significantly different between the TSD and DAT groups (88% vs. 83.9%, P = .92). However, approximation cost was significantly lower for DAT compared to TSD ($673.1 vs. $973.6; P = .002).

Similarly, complete closure rates were not significantly different between the TSD and DAT groups (92% vs. 93.5%, P = .83), but closure cost/mm² was significantly lower for DAT compared to TSD ($1.0/mm² vs. $1.6/mm²; P = .002).

Notably, the three DAT failures (60%) underwent successful tissue approximation with TSD, and the single TSD failure (33%) underwent successful tissue approximation using DAT.

In terms of speed, the averages for both tissue approximation time and closure speed were significantly faster in the DAT group, compared with the TSD group (12.2 minutes vs. 4 minutes, P < .0001; 72.7 mm²/min vs. 153.5 mm²/min; P = .003).

“The DAT clip was three times faster than the TSD,” Dr. Jawaid said in his presentation. Adverse events including device-related events, post–electrocautery syndrome, and delayed bleeding were similarly low with both devices. However, the DAT can be less effective in some circumstances, such as a closed space or difficult location. In the cases of duodenal defects, TSD was able to approximate all, but DAT was unable to approximate any. Reasons for DAT clip failure in these cases included the resection bed being too large and tissue tearing upon grasping. In the TSD group, the presence of looping was associated with failures for cecum and colon defects.
 

Data may inform device decisions

“This was an important study conducted to evaluate the different scope devices for defect closure,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and is executive vice chair of internal medicine at the University of Cincinnati.

“These devices have an impact on risk for delayed bleeding and perforation,” said Dr. Afzali, who served as moderator of the session in which the study was presented.

“With different items now available for defect closure, this randomized controlled study provides guidance on which TTS approximation device should be considered, and help determine effectiveness of defect closure,” she said.

“The results of this randomized controlled trial were very informative,” Dr. Afzali said. The data indicated that both DAT and TSD achieved similar rates of tissue approximation and complete closure, but “what was interesting was that one TSD is equivalent to two DAT for tissue approximation. Further, tissue approximation was three times faster with DAT, and complete closure costs were lower in the DAT-treated group.”

In clinical practice, “the study was able to help identify scenarios, such as resection beds involving greater than 50% circumference or defects located in the duodenum, where TSD is preferred over DAT for defect closure. These suggested scenarios are also important for clinical practice and device considerations,” Dr. Afzali said. “Additional studies with use of both devices, TSD and DAT simultaneously on a defect site may be needed to further assist endoscopists in defect management.”

The study was limited by the small size and use of data from a single center.

However, “based on our interim data, both devices are equally effective for tissue approximation of large endoscopic defects,” and facilitate complete defect closure, Dr. Jawaid said.

Ultimately, “both devices have a role,” with DAT being faster and likely more cost effective, while TSD is likely preferable for defects in the duodenum and those with a circumference greater than 50%, he said.

The study received no outside funding. Dr. Jawaid disclosed a consultancy with Boston Scientific, ConMed, CREO Speedboat, and DiLumen. Dr. Afzali disclosed numerous relationships with pharma including having served as an advisor/consultant for AbbVie, Bristol Myers Squibb/Celgene, Eli Lilly, and Gilead, among others.

Two novel devices are similarly effective for tissue approximation of large endoscopic resection defects, but each has advantages, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

“We know from previous data that defect closure is beneficial, and reduces complications such as delayed bleeding and delayed perforation,” said Salmaan A. Jawaid, MD, of Baylor College of Medicine, Houston, in a presentation at the meeting.

Baylor College of Medicine

In the past, defect closure was relatively straightforward; however, “the characteristics of these defects are evolving,” and defects are increasing in size, complexity, and number of locations, he said.

In response, management of resection defects has shifted from a one-step closure to a two-step process with approximation of the widest mucosal edges first, followed by complete resection bed closure, Dr. Jawaid said.

Two novel through the scope (TTS) tissue approximation devices used for the closure of large endoscopic resection defects – the dual-action tissue clip (DAT) and the TTS tack/suture device (TSD) – have not been directly compared on the basis of efficacy and cost, he said.

In the current study, Dr. Jawaid and colleagues randomized 56 adults undergoing tissue approximation and defect closure after endoscopic resection to DAT (31 patients) or TSD (25 patients). The patients were treated at a single center between August 2022 and May 2023 for closures of endoscopic resection defects including gastric, duodenum, and colon lesions greater than 20 mm wide and greater than 30 mm long.

The primary outcomes were technical success of tissue approximation and tissue approximation costs. Secondary outcomes were technical success of complete closure, closure costs, and speed of approximation and closure, as well as safety outcomes. Tissue approximation was defined as less than 15 mm of visible resection bed at the widest margin, and complete closure was defined as no visible resection bed.

Tissue approximation rates were not significantly different between the TSD and DAT groups (88% vs. 83.9%, P = .92). However, approximation cost was significantly lower for DAT compared to TSD ($673.1 vs. $973.6; P = .002).

Similarly, complete closure rates were not significantly different between the TSD and DAT groups (92% vs. 93.5%, P = .83), but closure cost/mm² was significantly lower for DAT compared to TSD ($1.0/mm² vs. $1.6/mm²; P = .002).

Notably, the three DAT failures (60%) underwent successful tissue approximation with TSD, and the single TSD failure (33%) underwent successful tissue approximation using DAT.

In terms of speed, the averages for both tissue approximation time and closure speed were significantly faster in the DAT group, compared with the TSD group (12.2 minutes vs. 4 minutes, P < .0001; 72.7 mm²/min vs. 153.5 mm²/min; P = .003).

“The DAT clip was three times faster than the TSD,” Dr. Jawaid said in his presentation. Adverse events including device-related events, post–electrocautery syndrome, and delayed bleeding were similarly low with both devices. However, the DAT can be less effective in some circumstances, such as a closed space or difficult location. In the cases of duodenal defects, TSD was able to approximate all, but DAT was unable to approximate any. Reasons for DAT clip failure in these cases included the resection bed being too large and tissue tearing upon grasping. In the TSD group, the presence of looping was associated with failures for cecum and colon defects.
 

Data may inform device decisions

“This was an important study conducted to evaluate the different scope devices for defect closure,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and is executive vice chair of internal medicine at the University of Cincinnati.

“These devices have an impact on risk for delayed bleeding and perforation,” said Dr. Afzali, who served as moderator of the session in which the study was presented.

“With different items now available for defect closure, this randomized controlled study provides guidance on which TTS approximation device should be considered, and help determine effectiveness of defect closure,” she said.

“The results of this randomized controlled trial were very informative,” Dr. Afzali said. The data indicated that both DAT and TSD achieved similar rates of tissue approximation and complete closure, but “what was interesting was that one TSD is equivalent to two DAT for tissue approximation. Further, tissue approximation was three times faster with DAT, and complete closure costs were lower in the DAT-treated group.”

In clinical practice, “the study was able to help identify scenarios, such as resection beds involving greater than 50% circumference or defects located in the duodenum, where TSD is preferred over DAT for defect closure. These suggested scenarios are also important for clinical practice and device considerations,” Dr. Afzali said. “Additional studies with use of both devices, TSD and DAT simultaneously on a defect site may be needed to further assist endoscopists in defect management.”

The study was limited by the small size and use of data from a single center.

However, “based on our interim data, both devices are equally effective for tissue approximation of large endoscopic defects,” and facilitate complete defect closure, Dr. Jawaid said.

Ultimately, “both devices have a role,” with DAT being faster and likely more cost effective, while TSD is likely preferable for defects in the duodenum and those with a circumference greater than 50%, he said.

The study received no outside funding. Dr. Jawaid disclosed a consultancy with Boston Scientific, ConMed, CREO Speedboat, and DiLumen. Dr. Afzali disclosed numerous relationships with pharma including having served as an advisor/consultant for AbbVie, Bristol Myers Squibb/Celgene, Eli Lilly, and Gilead, among others.