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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. 

Dr. Gyanprakash Ketwaroo
We look forward to hearing your thoughts on how endoscopy will continue to evolve @AGA_GIHN.

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.

Dr. Robert Jay Sealock, assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston
Dr. Robert Jay Sealock

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.

Dr. Thiru Muniraj, associate professor of medicine, Yale University, New Haven, Conn.
Dr. Thiru Muniraj

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.

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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. 

Dr. Gyanprakash Ketwaroo
We look forward to hearing your thoughts on how endoscopy will continue to evolve @AGA_GIHN.

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.

Dr. Robert Jay Sealock, assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston
Dr. Robert Jay Sealock

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.

Dr. Thiru Muniraj, associate professor of medicine, Yale University, New Haven, Conn.
Dr. Thiru Muniraj

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. 

Dr. Gyanprakash Ketwaroo
We look forward to hearing your thoughts on how endoscopy will continue to evolve @AGA_GIHN.

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.

Dr. Robert Jay Sealock, assistant professor of medicine, department of gastroenterology and hepatology, Baylor College of Medicine, Houston
Dr. Robert Jay Sealock

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.

Dr. Thiru Muniraj, associate professor of medicine, Yale University, New Haven, Conn.
Dr. Thiru Muniraj

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.

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