Endoscopy

Expert treatment centers should consider performing certain endoscopic ultrasound (EUS)-guided vascular interventions with current levels of supporting evidence, according to a practice update from the American Gastroenterological Association.

The AGA Institute’s Clinical Practice Update on interventional EUS, published in Clinical Gastroenterology and Hepatology , makes the case for broader adoption of two clinically available interventions – EUS-guided coil injection therapy of gastric varices and EUS-guided portosystemic pressure gradient measurement – while listing key research questions that remain to be answered. The update also describes current evidence for several emerging EUS interventions.

Brigham and Women's Hospital

The update’s authors, led by Marvin Ryou, MD, of Brigham and Women’s Hospital, Boston, advised, when available, EUS-guided coil injection therapy of gastric varices over conventional direct endoscopic injection with cyanoacrylate glue, noting that EUS guidance “enhances the precision of injection,” expands treatment options to include placement of hemostatic coils, and uses Doppler to provide real-time feedback on hemostasis.

Available evidence suggests that EUS-guided gastric variceal therapy is “safe, with excellent acute hemostasis and low re-bleeding rates, and likely superiority over traditional direct endoscopic glue injection,” Dr. Ryou and colleagues wrote in their update.

Nonetheless, they cautioned, “the development of a consensus technique would be helpful,” better training of technicians is needed, and large, multicenter studies comparing EUS with standard interventional radiology approaches are still needed.

EUS-guided direct measurement of the portosystemic pressure gradient (PPG) may offer improved clinical efficiency over a percutaneous endovascular approach, Dr. Ryou and colleagues determined, notably when there is concern for a pre-sinusoidal cause of portal hypertension. The EUS intervention allows for the “concurrent ability to perform esophagogastroduodenoscopy and EUS as a one-stop shop during which PPG, liver biopsy, and endoscopic features of portal hypertension … can all be evaluated, obtained, and potentially treated during a single procedure.” The authors updated guidance on four emerging interventions for which evidence remains limited: EUS-guided injection therapy of rectal varices, EUS-guided splenic artery embolization, EUS-guided injection therapy in patients with splenic artery pseudoaneurysms, and EUS-guided portal vein sampling.

While the last of these interventions appears safe, the authors cautioned, it should be performed only as part of a research protocol. The authors described an experimental intervention tested in animal models using a EUS-guided intrahepatic portosystemic shunt in which a self-expanding metal stent was deployed via EUS to bridge the hepatic and portal vein and decompress a hypertensive portal system.

The authors cautioned that the guidance was not the product of a formal systematic review, but represented a summary of practical advice gleaned from a literature review to provide practical advice. As a general rule, they said, EUS-guided vascular interventions should be considered when the vascular target occurs in or near the gastrointestinal wall, “which may confer an advantage to an endoscopic rather than percutaneous access,” and when the intervention has “a clinical efficacy and safety profile comparable, if not superior, to current alternatives.” All the interventions described in the clinical practice update satisfy the first condition, but not the second.

Dr. Ryou and two of his three coauthors disclosed financial relationships, including consulting fees and research support, from device manufacturers.

Expert treatment centers should consider performing certain endoscopic ultrasound (EUS)-guided vascular interventions with current levels of supporting evidence, according to a practice update from the American Gastroenterological Association.

The AGA Institute’s Clinical Practice Update on interventional EUS, published in Clinical Gastroenterology and Hepatology , makes the case for broader adoption of two clinically available interventions – EUS-guided coil injection therapy of gastric varices and EUS-guided portosystemic pressure gradient measurement – while listing key research questions that remain to be answered. The update also describes current evidence for several emerging EUS interventions.

Brigham and Women's Hospital

The update’s authors, led by Marvin Ryou, MD, of Brigham and Women’s Hospital, Boston, advised, when available, EUS-guided coil injection therapy of gastric varices over conventional direct endoscopic injection with cyanoacrylate glue, noting that EUS guidance “enhances the precision of injection,” expands treatment options to include placement of hemostatic coils, and uses Doppler to provide real-time feedback on hemostasis.

Available evidence suggests that EUS-guided gastric variceal therapy is “safe, with excellent acute hemostasis and low re-bleeding rates, and likely superiority over traditional direct endoscopic glue injection,” Dr. Ryou and colleagues wrote in their update.

Nonetheless, they cautioned, “the development of a consensus technique would be helpful,” better training of technicians is needed, and large, multicenter studies comparing EUS with standard interventional radiology approaches are still needed.

EUS-guided direct measurement of the portosystemic pressure gradient (PPG) may offer improved clinical efficiency over a percutaneous endovascular approach, Dr. Ryou and colleagues determined, notably when there is concern for a pre-sinusoidal cause of portal hypertension. The EUS intervention allows for the “concurrent ability to perform esophagogastroduodenoscopy and EUS as a one-stop shop during which PPG, liver biopsy, and endoscopic features of portal hypertension … can all be evaluated, obtained, and potentially treated during a single procedure.” The authors updated guidance on four emerging interventions for which evidence remains limited: EUS-guided injection therapy of rectal varices, EUS-guided splenic artery embolization, EUS-guided injection therapy in patients with splenic artery pseudoaneurysms, and EUS-guided portal vein sampling.

While the last of these interventions appears safe, the authors cautioned, it should be performed only as part of a research protocol. The authors described an experimental intervention tested in animal models using a EUS-guided intrahepatic portosystemic shunt in which a self-expanding metal stent was deployed via EUS to bridge the hepatic and portal vein and decompress a hypertensive portal system.

The authors cautioned that the guidance was not the product of a formal systematic review, but represented a summary of practical advice gleaned from a literature review to provide practical advice. As a general rule, they said, EUS-guided vascular interventions should be considered when the vascular target occurs in or near the gastrointestinal wall, “which may confer an advantage to an endoscopic rather than percutaneous access,” and when the intervention has “a clinical efficacy and safety profile comparable, if not superior, to current alternatives.” All the interventions described in the clinical practice update satisfy the first condition, but not the second.

Dr. Ryou and two of his three coauthors disclosed financial relationships, including consulting fees and research support, from device manufacturers.

Expert treatment centers should consider performing certain endoscopic ultrasound (EUS)-guided vascular interventions with current levels of supporting evidence, according to a practice update from the American Gastroenterological Association.

The AGA Institute’s Clinical Practice Update on interventional EUS, published in Clinical Gastroenterology and Hepatology , makes the case for broader adoption of two clinically available interventions – EUS-guided coil injection therapy of gastric varices and EUS-guided portosystemic pressure gradient measurement – while listing key research questions that remain to be answered. The update also describes current evidence for several emerging EUS interventions.

Brigham and Women's Hospital

The update’s authors, led by Marvin Ryou, MD, of Brigham and Women’s Hospital, Boston, advised, when available, EUS-guided coil injection therapy of gastric varices over conventional direct endoscopic injection with cyanoacrylate glue, noting that EUS guidance “enhances the precision of injection,” expands treatment options to include placement of hemostatic coils, and uses Doppler to provide real-time feedback on hemostasis.

Available evidence suggests that EUS-guided gastric variceal therapy is “safe, with excellent acute hemostasis and low re-bleeding rates, and likely superiority over traditional direct endoscopic glue injection,” Dr. Ryou and colleagues wrote in their update.

Nonetheless, they cautioned, “the development of a consensus technique would be helpful,” better training of technicians is needed, and large, multicenter studies comparing EUS with standard interventional radiology approaches are still needed.

EUS-guided direct measurement of the portosystemic pressure gradient (PPG) may offer improved clinical efficiency over a percutaneous endovascular approach, Dr. Ryou and colleagues determined, notably when there is concern for a pre-sinusoidal cause of portal hypertension. The EUS intervention allows for the “concurrent ability to perform esophagogastroduodenoscopy and EUS as a one-stop shop during which PPG, liver biopsy, and endoscopic features of portal hypertension … can all be evaluated, obtained, and potentially treated during a single procedure.” The authors updated guidance on four emerging interventions for which evidence remains limited: EUS-guided injection therapy of rectal varices, EUS-guided splenic artery embolization, EUS-guided injection therapy in patients with splenic artery pseudoaneurysms, and EUS-guided portal vein sampling.

While the last of these interventions appears safe, the authors cautioned, it should be performed only as part of a research protocol. The authors described an experimental intervention tested in animal models using a EUS-guided intrahepatic portosystemic shunt in which a self-expanding metal stent was deployed via EUS to bridge the hepatic and portal vein and decompress a hypertensive portal system.

The authors cautioned that the guidance was not the product of a formal systematic review, but represented a summary of practical advice gleaned from a literature review to provide practical advice. As a general rule, they said, EUS-guided vascular interventions should be considered when the vascular target occurs in or near the gastrointestinal wall, “which may confer an advantage to an endoscopic rather than percutaneous access,” and when the intervention has “a clinical efficacy and safety profile comparable, if not superior, to current alternatives.” All the interventions described in the clinical practice update satisfy the first condition, but not the second.

Dr. Ryou and two of his three coauthors disclosed financial relationships, including consulting fees and research support, from device manufacturers.

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

A version of this article first appeared on Medscape.com.

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

A version of this article first appeared on Medscape.com.

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

A version of this article first appeared on Medscape.com.

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

A version of this article originally appeared on Medscape.com.

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

A version of this article originally appeared on Medscape.com.

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

A version of this article originally appeared on Medscape.com.

Endoscopic ultrasound–guided gallbladder drainage (EUS-GBD) should be considered for patients with acute cholecystitis who are unable to undergo surgery, according to a recent clinical practice update by the American Gastroenterological Association.

The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.

“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.

Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.

According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.

Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.

While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.

“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”

Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.

Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”

This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.

Endoscopic ultrasound–guided gallbladder drainage (EUS-GBD) should be considered for patients with acute cholecystitis who are unable to undergo surgery, according to a recent clinical practice update by the American Gastroenterological Association.

The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.

“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.

Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.

According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.

Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.

While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.

“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”

Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.

Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”

This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.

Endoscopic ultrasound–guided gallbladder drainage (EUS-GBD) should be considered for patients with acute cholecystitis who are unable to undergo surgery, according to a recent clinical practice update by the American Gastroenterological Association.

The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.

“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.

Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.

According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.

Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.

While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.

“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”

Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.

Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”

This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.

Over-the-scope clips (OTSC) may prevent further bleeding more so than standard endoscopic treatment when used as primary treatment in patients with high-risk nonvariceal upper gastrointestinal lesions, shows a randomized controlled trial (RCT).

However, noted the investigators, writing in Annals of Internal Medicine, and physicians who wrote an accompanying editorial, reservations remain about first-line use of OTSCs, but mostly relate to method, technique, and cost.

“The absolute difference in the rate of further bleeding was 11.4 percentage points. We should however be cautious in our recommendation of using OTSC as first-line treatment,” wrote researchers who were led by James Y.W. Lau, MD, from Prince of Wales Hospital, Chinese University of Hong Kong.

“The primary use of OTSCs may find a role in the treatment of ulcers predicted to fail standard endoscopic treatment,” the authors wrote.  However, they emphasized that, “We are not advocating routine primary use of OTSCs. These clips are costly, and a formal cost analysis is not available in the literature. The use of OTSCs involves scope withdrawal, mounting of the OTSCs, and scope reinsertion, which increase the procedure time. Endoscopists also require training before using OTSCs.”

Alan N. Barkun, MD, gastroenterologist and professor of medicine with McGill University, Montreal, who cowrote the editorial accompanying the research paper, said the study investigators were highly experienced surgeon-scientists, pointing out that, overall, first-line use of OTSC in this patient group improved patient outcomes.

“The main message here is that if you can position the clip properly, then it is likely to stay in place, better than standard approaches,” he said, adding that, “I support it fully for second-line use but there currently still exists uncertainty for routine first-line adoption in nonvariceal bleeding. Clinicians fail to position the clip properly in around 5% of patients which is higher than standard endoscopic approaches, and nobody has yet clearly defined the lesions that are difficult to clip with the OTSC.

“If you’re going to tell people to use it, then you need to tell them with which particular lesions OTSC works best as first-line approach,” he added.

Lesions of concern include upon leaving the stomach and entering the duodenum, and in passing from the first to the second stage of the duodenum. “These are tight areas, and these larger full-thickness bite OTSC may create pseudo-polyps, even possibly causing obstruction. Perforation is also a risk.” One of each of these complications were noted in this study.

The study included 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Of these, 97 patients received standard hemostatic treatment and 93 received OTSC. The primary endpoint of a 30-day probability of further bleeding was 14.6% in the standard treatment and 3.2% in the OTSC group (risk difference, 11.4 percentage points [95% confidence interval (CI), 3.3-20.0 percentage points]; P = .006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 in the standard treatment and OTSC groups, respectively. Thirty-day recurrent bleeding was 8 versus 2 in the standard treatment and OTSC groups, respectively. Eight patients in the standard treatment group needed further intervention compared with two in the OTSC group. Thirty-day mortality was four versus two, respectively.

“First-line OTSC has a role to play but whether it is the best approach is hard to say due to methodological limitations that were seen in this and earlier studies, however if you can position the clip properly it likely does well,” Dr. Barkun said.

Dr. Lau declares that he received honorarium for a lecture from OVESCO. Dr. Li has no disclosures. Dr. Barkun has no relevant disclosures.  

Over-the-scope clips (OTSC) may prevent further bleeding more so than standard endoscopic treatment when used as primary treatment in patients with high-risk nonvariceal upper gastrointestinal lesions, shows a randomized controlled trial (RCT).

However, noted the investigators, writing in Annals of Internal Medicine, and physicians who wrote an accompanying editorial, reservations remain about first-line use of OTSCs, but mostly relate to method, technique, and cost.

“The absolute difference in the rate of further bleeding was 11.4 percentage points. We should however be cautious in our recommendation of using OTSC as first-line treatment,” wrote researchers who were led by James Y.W. Lau, MD, from Prince of Wales Hospital, Chinese University of Hong Kong.

“The primary use of OTSCs may find a role in the treatment of ulcers predicted to fail standard endoscopic treatment,” the authors wrote.  However, they emphasized that, “We are not advocating routine primary use of OTSCs. These clips are costly, and a formal cost analysis is not available in the literature. The use of OTSCs involves scope withdrawal, mounting of the OTSCs, and scope reinsertion, which increase the procedure time. Endoscopists also require training before using OTSCs.”

Alan N. Barkun, MD, gastroenterologist and professor of medicine with McGill University, Montreal, who cowrote the editorial accompanying the research paper, said the study investigators were highly experienced surgeon-scientists, pointing out that, overall, first-line use of OTSC in this patient group improved patient outcomes.

“The main message here is that if you can position the clip properly, then it is likely to stay in place, better than standard approaches,” he said, adding that, “I support it fully for second-line use but there currently still exists uncertainty for routine first-line adoption in nonvariceal bleeding. Clinicians fail to position the clip properly in around 5% of patients which is higher than standard endoscopic approaches, and nobody has yet clearly defined the lesions that are difficult to clip with the OTSC.

“If you’re going to tell people to use it, then you need to tell them with which particular lesions OTSC works best as first-line approach,” he added.

Lesions of concern include upon leaving the stomach and entering the duodenum, and in passing from the first to the second stage of the duodenum. “These are tight areas, and these larger full-thickness bite OTSC may create pseudo-polyps, even possibly causing obstruction. Perforation is also a risk.” One of each of these complications were noted in this study.

The study included 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Of these, 97 patients received standard hemostatic treatment and 93 received OTSC. The primary endpoint of a 30-day probability of further bleeding was 14.6% in the standard treatment and 3.2% in the OTSC group (risk difference, 11.4 percentage points [95% confidence interval (CI), 3.3-20.0 percentage points]; P = .006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 in the standard treatment and OTSC groups, respectively. Thirty-day recurrent bleeding was 8 versus 2 in the standard treatment and OTSC groups, respectively. Eight patients in the standard treatment group needed further intervention compared with two in the OTSC group. Thirty-day mortality was four versus two, respectively.

“First-line OTSC has a role to play but whether it is the best approach is hard to say due to methodological limitations that were seen in this and earlier studies, however if you can position the clip properly it likely does well,” Dr. Barkun said.

Dr. Lau declares that he received honorarium for a lecture from OVESCO. Dr. Li has no disclosures. Dr. Barkun has no relevant disclosures.  

Over-the-scope clips (OTSC) may prevent further bleeding more so than standard endoscopic treatment when used as primary treatment in patients with high-risk nonvariceal upper gastrointestinal lesions, shows a randomized controlled trial (RCT).

However, noted the investigators, writing in Annals of Internal Medicine, and physicians who wrote an accompanying editorial, reservations remain about first-line use of OTSCs, but mostly relate to method, technique, and cost.

“The absolute difference in the rate of further bleeding was 11.4 percentage points. We should however be cautious in our recommendation of using OTSC as first-line treatment,” wrote researchers who were led by James Y.W. Lau, MD, from Prince of Wales Hospital, Chinese University of Hong Kong.

“The primary use of OTSCs may find a role in the treatment of ulcers predicted to fail standard endoscopic treatment,” the authors wrote.  However, they emphasized that, “We are not advocating routine primary use of OTSCs. These clips are costly, and a formal cost analysis is not available in the literature. The use of OTSCs involves scope withdrawal, mounting of the OTSCs, and scope reinsertion, which increase the procedure time. Endoscopists also require training before using OTSCs.”

Alan N. Barkun, MD, gastroenterologist and professor of medicine with McGill University, Montreal, who cowrote the editorial accompanying the research paper, said the study investigators were highly experienced surgeon-scientists, pointing out that, overall, first-line use of OTSC in this patient group improved patient outcomes.

“The main message here is that if you can position the clip properly, then it is likely to stay in place, better than standard approaches,” he said, adding that, “I support it fully for second-line use but there currently still exists uncertainty for routine first-line adoption in nonvariceal bleeding. Clinicians fail to position the clip properly in around 5% of patients which is higher than standard endoscopic approaches, and nobody has yet clearly defined the lesions that are difficult to clip with the OTSC.

“If you’re going to tell people to use it, then you need to tell them with which particular lesions OTSC works best as first-line approach,” he added.

Lesions of concern include upon leaving the stomach and entering the duodenum, and in passing from the first to the second stage of the duodenum. “These are tight areas, and these larger full-thickness bite OTSC may create pseudo-polyps, even possibly causing obstruction. Perforation is also a risk.” One of each of these complications were noted in this study.

The study included 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Of these, 97 patients received standard hemostatic treatment and 93 received OTSC. The primary endpoint of a 30-day probability of further bleeding was 14.6% in the standard treatment and 3.2% in the OTSC group (risk difference, 11.4 percentage points [95% confidence interval (CI), 3.3-20.0 percentage points]; P = .006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 in the standard treatment and OTSC groups, respectively. Thirty-day recurrent bleeding was 8 versus 2 in the standard treatment and OTSC groups, respectively. Eight patients in the standard treatment group needed further intervention compared with two in the OTSC group. Thirty-day mortality was four versus two, respectively.

“First-line OTSC has a role to play but whether it is the best approach is hard to say due to methodological limitations that were seen in this and earlier studies, however if you can position the clip properly it likely does well,” Dr. Barkun said.

Dr. Lau declares that he received honorarium for a lecture from OVESCO. Dr. Li has no disclosures. Dr. Barkun has no relevant disclosures.  

Most older adults with low-risk surveillance colonoscopy findings and/or limited life expectancy are advised to undergo a repeat procedure in the future, according to a new study.

Among nearly 10,000 Medicare beneficiaries, the likelihood of finding advanced polyps or colorectal cancer (CRC) on surveillance colonoscopy was low. Yet, among patients for whom any follow-up recommendation – either for or against colonoscopy – was available, the vast majority (87%) were advised to return for the procedure in the future, even if their life expectancy was limited or there were no significant findings on their surveillance colonoscopy.

“These findings suggest that recommending against future surveillance colonoscopy in older adults with low-risk colonoscopy findings and/or limited life expectancy should be considered more frequently than is currently practiced,” say Audrey Calderwood, MD, with Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and colleagues.

Because of the lack of clear guidance about when to stop recommending colonoscopies to older patients, it is not surprising that physicians recommend surveillance even for patients with low life expectancy, Ziad Gellad, MD, with Duke University Medical Center, Durham, N.C., said in an interview.

“As someone who performs these procedures, I can tell you that it is not easy to tell patients that they are too old to get preventive care, especially patients in whom your only interaction is the procedure itself,” said Dr. Gellad, who wasn’t involved in the study.

The study was published online in JAMA Internal Medicine.
 

Key findings

For older adults, surveillance after prior findings of colon polyps is the most frequent indication for colonoscopy. Data suggest that an estimated 5.6 million adults older than 75 will undergo follow-up colonoscopy annually by 2024.

For older adults with polyps, current guidelines recommend individualized decision-making about surveillance colonoscopy. That includes weighing the potential benefits (identifying and removing meaningful lesions to prevent CRC) against the burdens and potential harms (such as bleeding or perforation).

While most colon polyps are not harmful, a subset of polyps, if allowed to grow, can develop into cancer over 10-15 years. This long biological time line highlights the importance of considering life expectancy in deciding for whom surveillance colonoscopy should be recommended, Dr. Calderwood and colleagues note.

Using data from the New Hampshire Colonoscopy Registry, which is linked with the Medicare claims database, they evaluated surveillance colonoscopy findings and follow-up advice according to severity of findings and patients’ estimated life expectancy for 9,831 adults (mean age, 73; 54% men).

Life expectancy was 10+ years for 57.5% of patients, 5 to less than 10 years for 35%, and less than 5 years for 7.5%.

Overall, 791 patients (8%) were found to have advanced polyps (7.8%) or CRC (0.2%) on surveillance colonoscopy.

Recommendations to stop or continue future colonoscopy were available for 5,281 patients (53.7%). Among them, 4,588 (86.9%) were recommended to return for future colonoscopy, even when there were no significant colonoscopy findings or the patient’s life expectancy was limited.

Compared with life expectancy of less than 5 years, longer life expectancy was associated with advice to return for future colonoscopy regardless of clinical findings, with adjusted odds ratios of 21.5 and 2.7, respectively, for life expectancy of 10 or more years and of 5 to less than 10 years.

Among patients with no significant findings, 95% of those with life expectancy of 10 or more years were recommended to undergo repeat colonoscopy down the road, compared with 58% of those with estimated life expectancy of less than 5 years.

Among patients expected to live 5 to less than 10 years, future repeat colonoscopy was recommended for 75% who had no significant findings, 82% with one or two small polyps, and 88% with multiple polyps, advanced polyps, or CRC.

The recommended time to repeat colonoscopy was greater than life expectancy for 6.6% of patients with less than 5 years of life expectancy and 6% with 5 to less than 10 years of life expectancy.
 

Nuanced decisions

The findings “may help refine decision-making” about the potential benefits and harms of pursuing or stopping surveillance colonoscopy for older adults who have a history of polyps, Dr. Calderwood and colleagues say.

The risk for a colonoscopy complication has been estimated at 26 per 1,000 people, they note. That’s nearly 10 times greater than the potential benefits seen in their study (that is, identification of CRC in 23 of 9,831 people, or about 2.3 per 1,000).

In the study cohort, 10% of patients had comorbid conditions that have been associated with a higher risk for colonoscopy complications. Those with life expectancy of less than 5 years had higher rates of inadequate bowel preparation, which also is associated with increased risk for colonoscopy complications, including perforation.

Dr. Calderwood and colleagues suggest that clinicians use evidence regarding life expectancy and neoplasia progression to modify their recommendations for surveillance colonoscopy for older adults in the following ways:

• If life expectancy is less than 5 years, recommend against surveillance.
• If life expectancy is 5 to less than 10 years and the patient has only low-risk polyps, recommend against surveillance.
• If the patient is healthy with a life expectancy of 10+ years and has recently been found to have advanced polyps, recommend future surveillance colonoscopy, with a caveat that the ultimate decision is dependent on health and priorities at the time the colonoscopy is due to be performed.
• If future health is unknown or unclear, avoid giving definitive recommendations for future surveillance to allow the flexibility of deciding on the basis of risk and benefit when the time comes.

In comments to this news organization, Dr. Gellad noted that an assessment of patient life expectancy “is not readily accessible at the point of care. These are nuanced decisions that require shared decision-making. Sometimes that is best handled outside the procedure setting.”

Support for the study was provided by the National Cancer Institute. The authors have disclosed no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and is a cofounder of Higgs Boson.

A version of this article originally appeared on Medscape.com.

Most older adults with low-risk surveillance colonoscopy findings and/or limited life expectancy are advised to undergo a repeat procedure in the future, according to a new study.

Among nearly 10,000 Medicare beneficiaries, the likelihood of finding advanced polyps or colorectal cancer (CRC) on surveillance colonoscopy was low. Yet, among patients for whom any follow-up recommendation – either for or against colonoscopy – was available, the vast majority (87%) were advised to return for the procedure in the future, even if their life expectancy was limited or there were no significant findings on their surveillance colonoscopy.

“These findings suggest that recommending against future surveillance colonoscopy in older adults with low-risk colonoscopy findings and/or limited life expectancy should be considered more frequently than is currently practiced,” say Audrey Calderwood, MD, with Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and colleagues.

Because of the lack of clear guidance about when to stop recommending colonoscopies to older patients, it is not surprising that physicians recommend surveillance even for patients with low life expectancy, Ziad Gellad, MD, with Duke University Medical Center, Durham, N.C., said in an interview.

“As someone who performs these procedures, I can tell you that it is not easy to tell patients that they are too old to get preventive care, especially patients in whom your only interaction is the procedure itself,” said Dr. Gellad, who wasn’t involved in the study.

The study was published online in JAMA Internal Medicine.
 

Key findings

For older adults, surveillance after prior findings of colon polyps is the most frequent indication for colonoscopy. Data suggest that an estimated 5.6 million adults older than 75 will undergo follow-up colonoscopy annually by 2024.

For older adults with polyps, current guidelines recommend individualized decision-making about surveillance colonoscopy. That includes weighing the potential benefits (identifying and removing meaningful lesions to prevent CRC) against the burdens and potential harms (such as bleeding or perforation).

While most colon polyps are not harmful, a subset of polyps, if allowed to grow, can develop into cancer over 10-15 years. This long biological time line highlights the importance of considering life expectancy in deciding for whom surveillance colonoscopy should be recommended, Dr. Calderwood and colleagues note.

Using data from the New Hampshire Colonoscopy Registry, which is linked with the Medicare claims database, they evaluated surveillance colonoscopy findings and follow-up advice according to severity of findings and patients’ estimated life expectancy for 9,831 adults (mean age, 73; 54% men).

Life expectancy was 10+ years for 57.5% of patients, 5 to less than 10 years for 35%, and less than 5 years for 7.5%.

Overall, 791 patients (8%) were found to have advanced polyps (7.8%) or CRC (0.2%) on surveillance colonoscopy.

Recommendations to stop or continue future colonoscopy were available for 5,281 patients (53.7%). Among them, 4,588 (86.9%) were recommended to return for future colonoscopy, even when there were no significant colonoscopy findings or the patient’s life expectancy was limited.

Compared with life expectancy of less than 5 years, longer life expectancy was associated with advice to return for future colonoscopy regardless of clinical findings, with adjusted odds ratios of 21.5 and 2.7, respectively, for life expectancy of 10 or more years and of 5 to less than 10 years.

Among patients with no significant findings, 95% of those with life expectancy of 10 or more years were recommended to undergo repeat colonoscopy down the road, compared with 58% of those with estimated life expectancy of less than 5 years.

Among patients expected to live 5 to less than 10 years, future repeat colonoscopy was recommended for 75% who had no significant findings, 82% with one or two small polyps, and 88% with multiple polyps, advanced polyps, or CRC.

The recommended time to repeat colonoscopy was greater than life expectancy for 6.6% of patients with less than 5 years of life expectancy and 6% with 5 to less than 10 years of life expectancy.
 

Nuanced decisions

The findings “may help refine decision-making” about the potential benefits and harms of pursuing or stopping surveillance colonoscopy for older adults who have a history of polyps, Dr. Calderwood and colleagues say.

The risk for a colonoscopy complication has been estimated at 26 per 1,000 people, they note. That’s nearly 10 times greater than the potential benefits seen in their study (that is, identification of CRC in 23 of 9,831 people, or about 2.3 per 1,000).

In the study cohort, 10% of patients had comorbid conditions that have been associated with a higher risk for colonoscopy complications. Those with life expectancy of less than 5 years had higher rates of inadequate bowel preparation, which also is associated with increased risk for colonoscopy complications, including perforation.

Dr. Calderwood and colleagues suggest that clinicians use evidence regarding life expectancy and neoplasia progression to modify their recommendations for surveillance colonoscopy for older adults in the following ways:

• If life expectancy is less than 5 years, recommend against surveillance.
• If life expectancy is 5 to less than 10 years and the patient has only low-risk polyps, recommend against surveillance.
• If the patient is healthy with a life expectancy of 10+ years and has recently been found to have advanced polyps, recommend future surveillance colonoscopy, with a caveat that the ultimate decision is dependent on health and priorities at the time the colonoscopy is due to be performed.
• If future health is unknown or unclear, avoid giving definitive recommendations for future surveillance to allow the flexibility of deciding on the basis of risk and benefit when the time comes.

In comments to this news organization, Dr. Gellad noted that an assessment of patient life expectancy “is not readily accessible at the point of care. These are nuanced decisions that require shared decision-making. Sometimes that is best handled outside the procedure setting.”

Support for the study was provided by the National Cancer Institute. The authors have disclosed no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and is a cofounder of Higgs Boson.

A version of this article originally appeared on Medscape.com.

Most older adults with low-risk surveillance colonoscopy findings and/or limited life expectancy are advised to undergo a repeat procedure in the future, according to a new study.

Among nearly 10,000 Medicare beneficiaries, the likelihood of finding advanced polyps or colorectal cancer (CRC) on surveillance colonoscopy was low. Yet, among patients for whom any follow-up recommendation – either for or against colonoscopy – was available, the vast majority (87%) were advised to return for the procedure in the future, even if their life expectancy was limited or there were no significant findings on their surveillance colonoscopy.

“These findings suggest that recommending against future surveillance colonoscopy in older adults with low-risk colonoscopy findings and/or limited life expectancy should be considered more frequently than is currently practiced,” say Audrey Calderwood, MD, with Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and colleagues.

Because of the lack of clear guidance about when to stop recommending colonoscopies to older patients, it is not surprising that physicians recommend surveillance even for patients with low life expectancy, Ziad Gellad, MD, with Duke University Medical Center, Durham, N.C., said in an interview.

“As someone who performs these procedures, I can tell you that it is not easy to tell patients that they are too old to get preventive care, especially patients in whom your only interaction is the procedure itself,” said Dr. Gellad, who wasn’t involved in the study.

The study was published online in JAMA Internal Medicine.
 

Key findings

For older adults, surveillance after prior findings of colon polyps is the most frequent indication for colonoscopy. Data suggest that an estimated 5.6 million adults older than 75 will undergo follow-up colonoscopy annually by 2024.

For older adults with polyps, current guidelines recommend individualized decision-making about surveillance colonoscopy. That includes weighing the potential benefits (identifying and removing meaningful lesions to prevent CRC) against the burdens and potential harms (such as bleeding or perforation).

While most colon polyps are not harmful, a subset of polyps, if allowed to grow, can develop into cancer over 10-15 years. This long biological time line highlights the importance of considering life expectancy in deciding for whom surveillance colonoscopy should be recommended, Dr. Calderwood and colleagues note.

Using data from the New Hampshire Colonoscopy Registry, which is linked with the Medicare claims database, they evaluated surveillance colonoscopy findings and follow-up advice according to severity of findings and patients’ estimated life expectancy for 9,831 adults (mean age, 73; 54% men).

Life expectancy was 10+ years for 57.5% of patients, 5 to less than 10 years for 35%, and less than 5 years for 7.5%.

Overall, 791 patients (8%) were found to have advanced polyps (7.8%) or CRC (0.2%) on surveillance colonoscopy.

Recommendations to stop or continue future colonoscopy were available for 5,281 patients (53.7%). Among them, 4,588 (86.9%) were recommended to return for future colonoscopy, even when there were no significant colonoscopy findings or the patient’s life expectancy was limited.

Compared with life expectancy of less than 5 years, longer life expectancy was associated with advice to return for future colonoscopy regardless of clinical findings, with adjusted odds ratios of 21.5 and 2.7, respectively, for life expectancy of 10 or more years and of 5 to less than 10 years.

Among patients with no significant findings, 95% of those with life expectancy of 10 or more years were recommended to undergo repeat colonoscopy down the road, compared with 58% of those with estimated life expectancy of less than 5 years.

Among patients expected to live 5 to less than 10 years, future repeat colonoscopy was recommended for 75% who had no significant findings, 82% with one or two small polyps, and 88% with multiple polyps, advanced polyps, or CRC.

The recommended time to repeat colonoscopy was greater than life expectancy for 6.6% of patients with less than 5 years of life expectancy and 6% with 5 to less than 10 years of life expectancy.
 

Nuanced decisions

The findings “may help refine decision-making” about the potential benefits and harms of pursuing or stopping surveillance colonoscopy for older adults who have a history of polyps, Dr. Calderwood and colleagues say.

The risk for a colonoscopy complication has been estimated at 26 per 1,000 people, they note. That’s nearly 10 times greater than the potential benefits seen in their study (that is, identification of CRC in 23 of 9,831 people, or about 2.3 per 1,000).

In the study cohort, 10% of patients had comorbid conditions that have been associated with a higher risk for colonoscopy complications. Those with life expectancy of less than 5 years had higher rates of inadequate bowel preparation, which also is associated with increased risk for colonoscopy complications, including perforation.

Dr. Calderwood and colleagues suggest that clinicians use evidence regarding life expectancy and neoplasia progression to modify their recommendations for surveillance colonoscopy for older adults in the following ways:

• If life expectancy is less than 5 years, recommend against surveillance.
• If life expectancy is 5 to less than 10 years and the patient has only low-risk polyps, recommend against surveillance.
• If the patient is healthy with a life expectancy of 10+ years and has recently been found to have advanced polyps, recommend future surveillance colonoscopy, with a caveat that the ultimate decision is dependent on health and priorities at the time the colonoscopy is due to be performed.
• If future health is unknown or unclear, avoid giving definitive recommendations for future surveillance to allow the flexibility of deciding on the basis of risk and benefit when the time comes.

In comments to this news organization, Dr. Gellad noted that an assessment of patient life expectancy “is not readily accessible at the point of care. These are nuanced decisions that require shared decision-making. Sometimes that is best handled outside the procedure setting.”

Support for the study was provided by the National Cancer Institute. The authors have disclosed no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and is a cofounder of Higgs Boson.

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

SAN FRANCISCO – No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

SAN FRANCISCO – No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

Computer-aided detection (CADe) during colonoscopy may not lead to major improvements in key measures, particularly in community-based settings, according to a new study.

In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.

“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.

“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”

The study was published online in the American Journal of Gastroenterology.
 

Analyzing detection rates

Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.

Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.

The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.

Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.

Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.

Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.

Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.

There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.

Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.

In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.

CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).

A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).

The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.

“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
 

Additional considerations

In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.

In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.

“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.

Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.

“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”

The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.

“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.

“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.

The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Computer-aided detection (CADe) during colonoscopy may not lead to major improvements in key measures, particularly in community-based settings, according to a new study.

In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.

“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.

“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”

The study was published online in the American Journal of Gastroenterology.
 

Analyzing detection rates

Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.

Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.

The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.

Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.

Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.

Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.

Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.

There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.

Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.

In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.

CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).

A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).

The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.

“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
 

Additional considerations

In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.

In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.

“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.

Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.

“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”

The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.

“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.

“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.

The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Computer-aided detection (CADe) during colonoscopy may not lead to major improvements in key measures, particularly in community-based settings, according to a new study.

In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.

“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.

“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”

The study was published online in the American Journal of Gastroenterology.
 

Analyzing detection rates

Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.

Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.

The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.

Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.

Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.

Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.

Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.

There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.

Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.

In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.

CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).

A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).

The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.

“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
 

Additional considerations

In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.

In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.

“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.

Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.

“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”

The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.

“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.

“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.

The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Dear colleagues,

We continue our theme of highlighting innovations in gastroenterology by exploring how endoscopy continues to blur the lines with surgery. In this issue of Perspectives, Dr. RJ Sealock, assistant professor of medicine at the Baylor College of Medicine, and Dr. Thiru Muniraj, associate professor of medicine at the Yale School of Medicine share their experiences performing minimally invasive alternatives to surgery, discussing both sides of gastrointestinal perforations – treating and creating. Dr. Sealock describes how we can “MacGyver” traditional surgical wound vacs to treat Boerhaave's, while Dr. Muniraj shows how lumen-apposing metal stents allow us to treat acute cholecystitis in poor surgical candidates. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
 

Endoscopic vacuum therapy for GI perforation

BY ROBERT JAY SEALOCK, MD

Gastrointestinal endoscopy has evolved from a diagnostic modality into a therapeutic tool used to treat a wide variety of luminal pathology. Endoscopic closure of full thickness injuries is a field that has rapidly expanded because of advanced endoscopic tissue resection and the need for subsequent defect closure as well as technological advances in closure devices such an endoscopic suturing platforms and large over-the-scope clips.

Prior to the advent of closure devices, endoscopic means of treating full thickness defects included through-the-scope (TTS) clips and fully covered metal stents. Given the small size, TTS clips are useful for mucosal closure but are limited in their ability to achieve full thickness closure. Fully covered metal stents utilized particularly for upper GI tract perforations and leaks are intended to divert gastrointestinal content away from the site of injury, thereby allowing secondary intention healing. Stents have several limitations, including frequent downstream migration and an inability to create a “watertight” seal in minimizing wound contamination. For decades, our surgical colleagues have utilized negative pressure wound therapy or vacuum therapy to expedite large wound closure. Given their familiarity with the technique, surgeons began adapting vacuum therapy for the treatment of postsurgical anastomotic leaks and fistulas particularly within the rectum.¹ Eventually, the same technique was applied to the treatment of upper GI tract anastomotic leaks.² Endoscopic vacuum therapy (EVT) overcomes many of the limitations of traditional endoscopic closure or diversion using covered stents through the use of suction to promote granulation tissue and aspirate infected wound contents.³

The approach to full thickness luminal injury must be individualized, but for a majority of indications EVT can be considered as a first-line approach. In our own experience, EVT closure can be achieved in more than 80% of patients with a variety of injuries such as iatrogenic endoscopic perforations (e.g., esophageal perforation during Savary dilation), surgical defects (sleeve gastrectomy leaks), and spontaneous perforations (e.g., Boerhaave syndrome). The initial step is endoscopic assessment of the luminal injury as well as the extraluminal cavity. In some situations, it is necessary to manually clean the defect cavity of necrotic material and food.

Once the cavity is cleaned and the size of the defect is assessed, the EVT device is manufactured at the bedside using commonly available materials and tools. A wound vacuum polyurethane sponge is affixed to a nasogastric tube, trimmed to the desired shape and size, and placed either within the defect cavity or within the GI lumen next to the defect opening.⁴ The EVT device is exchanged at an interval of 3-5 days, which allows the promotion of granulation tissue and subsequent downsizing as the cavity shrinks. In our series, an average number of five exchanges was necessary to achieve closure, with an average time to closure of 25 days.

Most experts would recommend initially placing the EVT device within the defect cavity. Once the cavity size can no longer accommodate the device, complete closure is achieved via intraluminal placement. The use of constant negative pressure (typically 150 mm to 175 mm Hg) prevents migration or dislodgement of the device.

For those who use EVT, there is some satisfaction from assembling and tailoring your own device, much like the protagonist in the 1980s television series “MacGyver,” who would manufacture devices out of readily available materials to address difficult and life-threatening situations. This need for self-assembly also has fostered ingenuity and creativity in the field, which can be found in social media and peer-reviewed sources.⁵ For some, however, the need to assemble your own device may be a deterrent. There is certainly an opportunity for commercialization and innovation, thereby putting Food and Drug Administration–approved devices into the hands of endoscopists. EVT is also a time- and labor-intensive therapy without specific reimbursement codes. Despite these limitations we continue to use and advocate for EVT given its clinical success in a population of patients with complex luminal injuries.


Dr. Sealock is assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston. He receives research funding from AbbVie and is a consultant to ConMed and Ambu.
 

References

1. Weidenhagen R et al. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surg Endosc Other Interv Tech. 2008;22(8):1818-25. doi: 10.1007/s00464-007-9706-x.

2. Wedemeyer J et al. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.

3. Mennigen R et al. Comparison of endoscopic vacuum therapy versus stent for anastomotic leak after esophagectomy. J Gastrointest Surg. 2015;19(7):1229-35.

4. Abdulsada M et al. Endoluminal vacuum therapy of esophageal perforations. VideoGIE. 2020;5(1):8-10. doi: 10.1016/j.vgie.2019.10.004

5. de Moura DTH et al. Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: Step-by-step process of manufacturing and its advantages. VideoGIE. 2021 Sep 4;6(12):523-8. doi: 10.1016/j.vgie.2021.08.002.

LAMS for gallbladder drainage

BY THIRU MUNIRAJ, MD, PHD, FACG, FRCP

Surgical cholecystectomy is the gold standard of treatment for acute cholecystitis (AC).¹ The morbidity and mortality rates remain high in high-risk surgical patients, such as those with cirrhosis, coagulopathy, advanced malignancy, severe cardiopulmonary conditions, or poor performance status. Percutaneous gallbladder drainage (PT-GBD) typically has been performed as an alternative in these cases. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is rapidly becoming a preferred alternative treatment to surgery in the case of AC at expert centers.

Since Baron and Topazian introduced EUS-GBD using a double pigtail stent in 2007, the procedure has evolved with the introduction of dedicated newly developed short, bi-flanged, covered lumen-apposing metal stents (LAMS) that have revolutionized this procedure as a single-step technique with excellent efficacy and safety outcomes. Although EUS-GBD is widely adopted among endosonographers, several skilled ERCP [endoscopic retrograde cholangiopancreatography] endoscopists still perform endoscopic transpapillary gallbladder drainage (ET-GBD) with ERCP as an alternative for high-risk surgical patients with AC. However, three-way comparative studies and randomized trials between PT-GBD, ETGBD, and EUS-GBD have clearly shown that EUS-GBD with LAMS is the most effective and safer alternative with the lowest rate of recurrent cholecystitis.^2,3 The recent Tokyo Guidelines 2018 now suggest EUS-GBD as one of the viable options for AC treatment.⁴

In my institution, we offer EUS-GBD for nonsurgical candidates with AC with and without gallstones. In addition to its excellent benefits on quality of life through avoidance of an external percutaneous drain, EUS-GBD offers the ability to remove gallstones endoscopically using irrigation, suction, basket, and direct electrohydraulic lithotripsy. Moreover, EUS-GBD allows direct visualization and mucosal evaluation of the gallbladder when dysplasia or malignancy is suspected. The other indications where I perform EUS-GBD drainage are conversion of PT-GBD to EUS-GBD and as a backdoor alternate to failed ERCP where the cystic duct is patent and EUS-bile duct drainage is not amenable. In nonoperative malignant biliary stricture patients with indwelling metal biliary stents covering the cystic duct, I have a low threshold to perform a prophylactic EUS-GBD if the gallbladder is distended.

I perform EUS-GBD procedures under propofol intravenous anesthesia with the patient in the left lateral position on the fluoroscopy table. I choose the site to create the fistula for EUS-GBD either in the duodenal bulb or gastric antrum, whichever seems safer and easier to deploy the LAMS stent without torquing the endoscope much. In case of inadvertent complications such as stent maldeployment, the gastric site is often very forgiving. My preferred stent for EUS-GBD is 10 mm x 10 mm LAMS with hot cautery, as this seems to be the ideal size. We can choose a 10 mm x 15 mm stent if a larger stone removal is expected. I never choose smaller LAMS stents (6 mm and 8 mm), as the saddle length is not enough to bridge the thickened gallbladder wall and the thick gastric antral wall. In patients with calculous cholecystitis, I prefer to place a 7Fr 4cm pigtail plastic stent within the lumen of LAMS to ensure patency, especially if it is a gastric site, as food occlusion is more common. Unlike with pseudocyst drainage, these LAMS for EUS-GBD can be left indefinitely without removal. I avoid EUS-GBD in patients who have large-volume ascites or are too sick to tolerate anesthesia. Although a subsequent cholecystectomy post EUS-GBD is doable, I have a clear discussion with the surgeon before choosing this approach over ERCP ET-GBD in case future surgery is still an option. This is more important in patients who are awaiting liver transplantation.

The first step in establishing a program for EUS-GBD is to establish strong collaboration with your surgeons. In our institution, once our surgeons determine that patients with AC are high risk for surgery, they initiate a multidisciplinary discussion and reach out to advanced endoscopists at the same time or before consulting interventional radiology. The key to establishing a successful EUS-GBD program is to get “buy-in” from the surgeons and create a “signature” pathway for AC in your own institution.

EUS-GBD to drain the gallbladder in nonsurgical patients is one of my favorite procedures. Until the currently available LAMS secures an on-label indication for AC, we must wait and watch to see if there are enough advanced endoscopists ready to take over the challenge of all nonsurgical cholecystitis gallbladders – especially during late-night calls – rather than requesting PT-GBD. Soon, EUS-GBD will consign PT-GBD to centers without access to advanced endoscopists who perform EUS-guided interventions and limit ERCP transpapillary ET-GBD to patients with coagulopathy or large ascites.

Dr. Muniraj is associate professor of medicine, Yale School of Medicine, New Haven, Conn., and a consultant to Boston Scientific.
 

References

1. Endo I et al. Optimal treatment strategy for acute cholecystitis based on predictive factors: Japan-Taiwan multicenter cohort study. J Hepatobiliary Pancreat Sci. 2017. 24(6):346-61.

2. Siddiqui A et al. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an international, multicenter study. Surg Endosc. 2019;33(4):1260-70.

3. Teoh AYB et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: An international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020;69(6):1085-91.

4. Mori Y et al. Tokyo Guidelines 2018: Management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):87-95.

Dear colleagues,

We continue our theme of highlighting innovations in gastroenterology by exploring how endoscopy continues to blur the lines with surgery. In this issue of Perspectives, Dr. RJ Sealock, assistant professor of medicine at the Baylor College of Medicine, and Dr. Thiru Muniraj, associate professor of medicine at the Yale School of Medicine share their experiences performing minimally invasive alternatives to surgery, discussing both sides of gastrointestinal perforations – treating and creating. Dr. Sealock describes how we can “MacGyver” traditional surgical wound vacs to treat Boerhaave's, while Dr. Muniraj shows how lumen-apposing metal stents allow us to treat acute cholecystitis in poor surgical candidates. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
 

Endoscopic vacuum therapy for GI perforation

BY ROBERT JAY SEALOCK, MD

Gastrointestinal endoscopy has evolved from a diagnostic modality into a therapeutic tool used to treat a wide variety of luminal pathology. Endoscopic closure of full thickness injuries is a field that has rapidly expanded because of advanced endoscopic tissue resection and the need for subsequent defect closure as well as technological advances in closure devices such an endoscopic suturing platforms and large over-the-scope clips.

Prior to the advent of closure devices, endoscopic means of treating full thickness defects included through-the-scope (TTS) clips and fully covered metal stents. Given the small size, TTS clips are useful for mucosal closure but are limited in their ability to achieve full thickness closure. Fully covered metal stents utilized particularly for upper GI tract perforations and leaks are intended to divert gastrointestinal content away from the site of injury, thereby allowing secondary intention healing. Stents have several limitations, including frequent downstream migration and an inability to create a “watertight” seal in minimizing wound contamination. For decades, our surgical colleagues have utilized negative pressure wound therapy or vacuum therapy to expedite large wound closure. Given their familiarity with the technique, surgeons began adapting vacuum therapy for the treatment of postsurgical anastomotic leaks and fistulas particularly within the rectum.¹ Eventually, the same technique was applied to the treatment of upper GI tract anastomotic leaks.² Endoscopic vacuum therapy (EVT) overcomes many of the limitations of traditional endoscopic closure or diversion using covered stents through the use of suction to promote granulation tissue and aspirate infected wound contents.³

The approach to full thickness luminal injury must be individualized, but for a majority of indications EVT can be considered as a first-line approach. In our own experience, EVT closure can be achieved in more than 80% of patients with a variety of injuries such as iatrogenic endoscopic perforations (e.g., esophageal perforation during Savary dilation), surgical defects (sleeve gastrectomy leaks), and spontaneous perforations (e.g., Boerhaave syndrome). The initial step is endoscopic assessment of the luminal injury as well as the extraluminal cavity. In some situations, it is necessary to manually clean the defect cavity of necrotic material and food.

Once the cavity is cleaned and the size of the defect is assessed, the EVT device is manufactured at the bedside using commonly available materials and tools. A wound vacuum polyurethane sponge is affixed to a nasogastric tube, trimmed to the desired shape and size, and placed either within the defect cavity or within the GI lumen next to the defect opening.⁴ The EVT device is exchanged at an interval of 3-5 days, which allows the promotion of granulation tissue and subsequent downsizing as the cavity shrinks. In our series, an average number of five exchanges was necessary to achieve closure, with an average time to closure of 25 days.

Most experts would recommend initially placing the EVT device within the defect cavity. Once the cavity size can no longer accommodate the device, complete closure is achieved via intraluminal placement. The use of constant negative pressure (typically 150 mm to 175 mm Hg) prevents migration or dislodgement of the device.

For those who use EVT, there is some satisfaction from assembling and tailoring your own device, much like the protagonist in the 1980s television series “MacGyver,” who would manufacture devices out of readily available materials to address difficult and life-threatening situations. This need for self-assembly also has fostered ingenuity and creativity in the field, which can be found in social media and peer-reviewed sources.⁵ For some, however, the need to assemble your own device may be a deterrent. There is certainly an opportunity for commercialization and innovation, thereby putting Food and Drug Administration–approved devices into the hands of endoscopists. EVT is also a time- and labor-intensive therapy without specific reimbursement codes. Despite these limitations we continue to use and advocate for EVT given its clinical success in a population of patients with complex luminal injuries.


Dr. Sealock is assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston. He receives research funding from AbbVie and is a consultant to ConMed and Ambu.
 

References

1. Weidenhagen R et al. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surg Endosc Other Interv Tech. 2008;22(8):1818-25. doi: 10.1007/s00464-007-9706-x.

2. Wedemeyer J et al. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.

3. Mennigen R et al. Comparison of endoscopic vacuum therapy versus stent for anastomotic leak after esophagectomy. J Gastrointest Surg. 2015;19(7):1229-35.

4. Abdulsada M et al. Endoluminal vacuum therapy of esophageal perforations. VideoGIE. 2020;5(1):8-10. doi: 10.1016/j.vgie.2019.10.004

5. de Moura DTH et al. Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: Step-by-step process of manufacturing and its advantages. VideoGIE. 2021 Sep 4;6(12):523-8. doi: 10.1016/j.vgie.2021.08.002.

LAMS for gallbladder drainage

BY THIRU MUNIRAJ, MD, PHD, FACG, FRCP

Surgical cholecystectomy is the gold standard of treatment for acute cholecystitis (AC).¹ The morbidity and mortality rates remain high in high-risk surgical patients, such as those with cirrhosis, coagulopathy, advanced malignancy, severe cardiopulmonary conditions, or poor performance status. Percutaneous gallbladder drainage (PT-GBD) typically has been performed as an alternative in these cases. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is rapidly becoming a preferred alternative treatment to surgery in the case of AC at expert centers.

Since Baron and Topazian introduced EUS-GBD using a double pigtail stent in 2007, the procedure has evolved with the introduction of dedicated newly developed short, bi-flanged, covered lumen-apposing metal stents (LAMS) that have revolutionized this procedure as a single-step technique with excellent efficacy and safety outcomes. Although EUS-GBD is widely adopted among endosonographers, several skilled ERCP [endoscopic retrograde cholangiopancreatography] endoscopists still perform endoscopic transpapillary gallbladder drainage (ET-GBD) with ERCP as an alternative for high-risk surgical patients with AC. However, three-way comparative studies and randomized trials between PT-GBD, ETGBD, and EUS-GBD have clearly shown that EUS-GBD with LAMS is the most effective and safer alternative with the lowest rate of recurrent cholecystitis.^2,3 The recent Tokyo Guidelines 2018 now suggest EUS-GBD as one of the viable options for AC treatment.⁴

In my institution, we offer EUS-GBD for nonsurgical candidates with AC with and without gallstones. In addition to its excellent benefits on quality of life through avoidance of an external percutaneous drain, EUS-GBD offers the ability to remove gallstones endoscopically using irrigation, suction, basket, and direct electrohydraulic lithotripsy. Moreover, EUS-GBD allows direct visualization and mucosal evaluation of the gallbladder when dysplasia or malignancy is suspected. The other indications where I perform EUS-GBD drainage are conversion of PT-GBD to EUS-GBD and as a backdoor alternate to failed ERCP where the cystic duct is patent and EUS-bile duct drainage is not amenable. In nonoperative malignant biliary stricture patients with indwelling metal biliary stents covering the cystic duct, I have a low threshold to perform a prophylactic EUS-GBD if the gallbladder is distended.

I perform EUS-GBD procedures under propofol intravenous anesthesia with the patient in the left lateral position on the fluoroscopy table. I choose the site to create the fistula for EUS-GBD either in the duodenal bulb or gastric antrum, whichever seems safer and easier to deploy the LAMS stent without torquing the endoscope much. In case of inadvertent complications such as stent maldeployment, the gastric site is often very forgiving. My preferred stent for EUS-GBD is 10 mm x 10 mm LAMS with hot cautery, as this seems to be the ideal size. We can choose a 10 mm x 15 mm stent if a larger stone removal is expected. I never choose smaller LAMS stents (6 mm and 8 mm), as the saddle length is not enough to bridge the thickened gallbladder wall and the thick gastric antral wall. In patients with calculous cholecystitis, I prefer to place a 7Fr 4cm pigtail plastic stent within the lumen of LAMS to ensure patency, especially if it is a gastric site, as food occlusion is more common. Unlike with pseudocyst drainage, these LAMS for EUS-GBD can be left indefinitely without removal. I avoid EUS-GBD in patients who have large-volume ascites or are too sick to tolerate anesthesia. Although a subsequent cholecystectomy post EUS-GBD is doable, I have a clear discussion with the surgeon before choosing this approach over ERCP ET-GBD in case future surgery is still an option. This is more important in patients who are awaiting liver transplantation.

The first step in establishing a program for EUS-GBD is to establish strong collaboration with your surgeons. In our institution, once our surgeons determine that patients with AC are high risk for surgery, they initiate a multidisciplinary discussion and reach out to advanced endoscopists at the same time or before consulting interventional radiology. The key to establishing a successful EUS-GBD program is to get “buy-in” from the surgeons and create a “signature” pathway for AC in your own institution.

EUS-GBD to drain the gallbladder in nonsurgical patients is one of my favorite procedures. Until the currently available LAMS secures an on-label indication for AC, we must wait and watch to see if there are enough advanced endoscopists ready to take over the challenge of all nonsurgical cholecystitis gallbladders – especially during late-night calls – rather than requesting PT-GBD. Soon, EUS-GBD will consign PT-GBD to centers without access to advanced endoscopists who perform EUS-guided interventions and limit ERCP transpapillary ET-GBD to patients with coagulopathy or large ascites.

Dr. Muniraj is associate professor of medicine, Yale School of Medicine, New Haven, Conn., and a consultant to Boston Scientific.
 

References

1. Endo I et al. Optimal treatment strategy for acute cholecystitis based on predictive factors: Japan-Taiwan multicenter cohort study. J Hepatobiliary Pancreat Sci. 2017. 24(6):346-61.

2. Siddiqui A et al. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an international, multicenter study. Surg Endosc. 2019;33(4):1260-70.

3. Teoh AYB et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: An international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020;69(6):1085-91.

4. Mori Y et al. Tokyo Guidelines 2018: Management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):87-95.

Dear colleagues,

We continue our theme of highlighting innovations in gastroenterology by exploring how endoscopy continues to blur the lines with surgery. In this issue of Perspectives, Dr. RJ Sealock, assistant professor of medicine at the Baylor College of Medicine, and Dr. Thiru Muniraj, associate professor of medicine at the Yale School of Medicine share their experiences performing minimally invasive alternatives to surgery, discussing both sides of gastrointestinal perforations – treating and creating. Dr. Sealock describes how we can “MacGyver” traditional surgical wound vacs to treat Boerhaave's, while Dr. Muniraj shows how lumen-apposing metal stents allow us to treat acute cholecystitis in poor surgical candidates. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
 

Endoscopic vacuum therapy for GI perforation

BY ROBERT JAY SEALOCK, MD

Gastrointestinal endoscopy has evolved from a diagnostic modality into a therapeutic tool used to treat a wide variety of luminal pathology. Endoscopic closure of full thickness injuries is a field that has rapidly expanded because of advanced endoscopic tissue resection and the need for subsequent defect closure as well as technological advances in closure devices such an endoscopic suturing platforms and large over-the-scope clips.

Prior to the advent of closure devices, endoscopic means of treating full thickness defects included through-the-scope (TTS) clips and fully covered metal stents. Given the small size, TTS clips are useful for mucosal closure but are limited in their ability to achieve full thickness closure. Fully covered metal stents utilized particularly for upper GI tract perforations and leaks are intended to divert gastrointestinal content away from the site of injury, thereby allowing secondary intention healing. Stents have several limitations, including frequent downstream migration and an inability to create a “watertight” seal in minimizing wound contamination. For decades, our surgical colleagues have utilized negative pressure wound therapy or vacuum therapy to expedite large wound closure. Given their familiarity with the technique, surgeons began adapting vacuum therapy for the treatment of postsurgical anastomotic leaks and fistulas particularly within the rectum.¹ Eventually, the same technique was applied to the treatment of upper GI tract anastomotic leaks.² Endoscopic vacuum therapy (EVT) overcomes many of the limitations of traditional endoscopic closure or diversion using covered stents through the use of suction to promote granulation tissue and aspirate infected wound contents.³

The approach to full thickness luminal injury must be individualized, but for a majority of indications EVT can be considered as a first-line approach. In our own experience, EVT closure can be achieved in more than 80% of patients with a variety of injuries such as iatrogenic endoscopic perforations (e.g., esophageal perforation during Savary dilation), surgical defects (sleeve gastrectomy leaks), and spontaneous perforations (e.g., Boerhaave syndrome). The initial step is endoscopic assessment of the luminal injury as well as the extraluminal cavity. In some situations, it is necessary to manually clean the defect cavity of necrotic material and food.

Once the cavity is cleaned and the size of the defect is assessed, the EVT device is manufactured at the bedside using commonly available materials and tools. A wound vacuum polyurethane sponge is affixed to a nasogastric tube, trimmed to the desired shape and size, and placed either within the defect cavity or within the GI lumen next to the defect opening.⁴ The EVT device is exchanged at an interval of 3-5 days, which allows the promotion of granulation tissue and subsequent downsizing as the cavity shrinks. In our series, an average number of five exchanges was necessary to achieve closure, with an average time to closure of 25 days.

Most experts would recommend initially placing the EVT device within the defect cavity. Once the cavity size can no longer accommodate the device, complete closure is achieved via intraluminal placement. The use of constant negative pressure (typically 150 mm to 175 mm Hg) prevents migration or dislodgement of the device.

For those who use EVT, there is some satisfaction from assembling and tailoring your own device, much like the protagonist in the 1980s television series “MacGyver,” who would manufacture devices out of readily available materials to address difficult and life-threatening situations. This need for self-assembly also has fostered ingenuity and creativity in the field, which can be found in social media and peer-reviewed sources.⁵ For some, however, the need to assemble your own device may be a deterrent. There is certainly an opportunity for commercialization and innovation, thereby putting Food and Drug Administration–approved devices into the hands of endoscopists. EVT is also a time- and labor-intensive therapy without specific reimbursement codes. Despite these limitations we continue to use and advocate for EVT given its clinical success in a population of patients with complex luminal injuries.


Dr. Sealock is assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston. He receives research funding from AbbVie and is a consultant to ConMed and Ambu.
 

References

1. Weidenhagen R et al. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surg Endosc Other Interv Tech. 2008;22(8):1818-25. doi: 10.1007/s00464-007-9706-x.

2. Wedemeyer J et al. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.

3. Mennigen R et al. Comparison of endoscopic vacuum therapy versus stent for anastomotic leak after esophagectomy. J Gastrointest Surg. 2015;19(7):1229-35.

4. Abdulsada M et al. Endoluminal vacuum therapy of esophageal perforations. VideoGIE. 2020;5(1):8-10. doi: 10.1016/j.vgie.2019.10.004

5. de Moura DTH et al. Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: Step-by-step process of manufacturing and its advantages. VideoGIE. 2021 Sep 4;6(12):523-8. doi: 10.1016/j.vgie.2021.08.002.

LAMS for gallbladder drainage

BY THIRU MUNIRAJ, MD, PHD, FACG, FRCP

Surgical cholecystectomy is the gold standard of treatment for acute cholecystitis (AC).¹ The morbidity and mortality rates remain high in high-risk surgical patients, such as those with cirrhosis, coagulopathy, advanced malignancy, severe cardiopulmonary conditions, or poor performance status. Percutaneous gallbladder drainage (PT-GBD) typically has been performed as an alternative in these cases. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is rapidly becoming a preferred alternative treatment to surgery in the case of AC at expert centers.

Since Baron and Topazian introduced EUS-GBD using a double pigtail stent in 2007, the procedure has evolved with the introduction of dedicated newly developed short, bi-flanged, covered lumen-apposing metal stents (LAMS) that have revolutionized this procedure as a single-step technique with excellent efficacy and safety outcomes. Although EUS-GBD is widely adopted among endosonographers, several skilled ERCP [endoscopic retrograde cholangiopancreatography] endoscopists still perform endoscopic transpapillary gallbladder drainage (ET-GBD) with ERCP as an alternative for high-risk surgical patients with AC. However, three-way comparative studies and randomized trials between PT-GBD, ETGBD, and EUS-GBD have clearly shown that EUS-GBD with LAMS is the most effective and safer alternative with the lowest rate of recurrent cholecystitis.^2,3 The recent Tokyo Guidelines 2018 now suggest EUS-GBD as one of the viable options for AC treatment.⁴

In my institution, we offer EUS-GBD for nonsurgical candidates with AC with and without gallstones. In addition to its excellent benefits on quality of life through avoidance of an external percutaneous drain, EUS-GBD offers the ability to remove gallstones endoscopically using irrigation, suction, basket, and direct electrohydraulic lithotripsy. Moreover, EUS-GBD allows direct visualization and mucosal evaluation of the gallbladder when dysplasia or malignancy is suspected. The other indications where I perform EUS-GBD drainage are conversion of PT-GBD to EUS-GBD and as a backdoor alternate to failed ERCP where the cystic duct is patent and EUS-bile duct drainage is not amenable. In nonoperative malignant biliary stricture patients with indwelling metal biliary stents covering the cystic duct, I have a low threshold to perform a prophylactic EUS-GBD if the gallbladder is distended.

I perform EUS-GBD procedures under propofol intravenous anesthesia with the patient in the left lateral position on the fluoroscopy table. I choose the site to create the fistula for EUS-GBD either in the duodenal bulb or gastric antrum, whichever seems safer and easier to deploy the LAMS stent without torquing the endoscope much. In case of inadvertent complications such as stent maldeployment, the gastric site is often very forgiving. My preferred stent for EUS-GBD is 10 mm x 10 mm LAMS with hot cautery, as this seems to be the ideal size. We can choose a 10 mm x 15 mm stent if a larger stone removal is expected. I never choose smaller LAMS stents (6 mm and 8 mm), as the saddle length is not enough to bridge the thickened gallbladder wall and the thick gastric antral wall. In patients with calculous cholecystitis, I prefer to place a 7Fr 4cm pigtail plastic stent within the lumen of LAMS to ensure patency, especially if it is a gastric site, as food occlusion is more common. Unlike with pseudocyst drainage, these LAMS for EUS-GBD can be left indefinitely without removal. I avoid EUS-GBD in patients who have large-volume ascites or are too sick to tolerate anesthesia. Although a subsequent cholecystectomy post EUS-GBD is doable, I have a clear discussion with the surgeon before choosing this approach over ERCP ET-GBD in case future surgery is still an option. This is more important in patients who are awaiting liver transplantation.

The first step in establishing a program for EUS-GBD is to establish strong collaboration with your surgeons. In our institution, once our surgeons determine that patients with AC are high risk for surgery, they initiate a multidisciplinary discussion and reach out to advanced endoscopists at the same time or before consulting interventional radiology. The key to establishing a successful EUS-GBD program is to get “buy-in” from the surgeons and create a “signature” pathway for AC in your own institution.

EUS-GBD to drain the gallbladder in nonsurgical patients is one of my favorite procedures. Until the currently available LAMS secures an on-label indication for AC, we must wait and watch to see if there are enough advanced endoscopists ready to take over the challenge of all nonsurgical cholecystitis gallbladders – especially during late-night calls – rather than requesting PT-GBD. Soon, EUS-GBD will consign PT-GBD to centers without access to advanced endoscopists who perform EUS-guided interventions and limit ERCP transpapillary ET-GBD to patients with coagulopathy or large ascites.

Dr. Muniraj is associate professor of medicine, Yale School of Medicine, New Haven, Conn., and a consultant to Boston Scientific.
 

References

1. Endo I et al. Optimal treatment strategy for acute cholecystitis based on predictive factors: Japan-Taiwan multicenter cohort study. J Hepatobiliary Pancreat Sci. 2017. 24(6):346-61.

2. Siddiqui A et al. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an international, multicenter study. Surg Endosc. 2019;33(4):1260-70.

3. Teoh AYB et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: An international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020;69(6):1085-91.

4. Mori Y et al. Tokyo Guidelines 2018: Management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):87-95.

Cold snare polypectomy (CSP) is superior to hot snare polypectomy (HSP) for colorectal polyps measuring 4-10 mm, a pragmatic randomized controlled trial confirms.

In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.

The study was published online in Annals of Internal Medicine.

This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.

“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.

Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.

To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.

Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).

Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).

The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).

CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.

“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.

“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.

Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.

“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.

The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
 

A version of this article first appeared on Medscape.com.

Cold snare polypectomy (CSP) is superior to hot snare polypectomy (HSP) for colorectal polyps measuring 4-10 mm, a pragmatic randomized controlled trial confirms.

In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.

The study was published online in Annals of Internal Medicine.

This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.

“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.

Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.

To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.

Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).

Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).

The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).

CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.

“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.

“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.

Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.

“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.

The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
 

A version of this article first appeared on Medscape.com.

Cold snare polypectomy (CSP) is superior to hot snare polypectomy (HSP) for colorectal polyps measuring 4-10 mm, a pragmatic randomized controlled trial confirms.

In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.

The study was published online in Annals of Internal Medicine.

This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.

“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.

Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.

To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.

Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).

Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).

The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).

CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.

“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.

“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.

Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.

“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.

The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
 

A version of this article first appeared on Medscape.com.