- Email: [email protected]
Internal EUS-Directed Transgastric ERCP (EDGE): Game Over
GASTROENTEROLOGY IN MOTION Ralf Kiesslich and Thomas D. Wang, Section Editors
Internal EUS-Directed Transgastric ERCP (EDGE): Game Over Prashant Kedia, Reem Z. Sharaiha, Nikhil A. Kumta, and Michel Kahaleh Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York
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A
s the prevalence of obesity in the United States exceeds 30%, the number of bariatric procedures being performed, including Roux-en-Y gastric bypass (RYGB), is steadily increasing.1 Therefore, gastroenterologists will inevitably be required to manage pancreaticobiliary diseases in more patients with altered anatomy. Various techniques including deep enteroscopy-assisted endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopy-assisted ERCP have been developed to address the anatomic challenges of these patients. However, they are not without their limitations. Technical success rates of enteroscopy-assisted ERCP have been reported to be as low as 63% in multicenter trials.2 Alternatively, whereas laparoscopy-assisted ERCP has high technical success rates, it carries significant risk of complications and is more costly.3,4 Therefore, efforts by endoscopists have been focused on gaining endoscopic access to the excluded stomach to perform conventional antegrade ERCP. A recently published case series described using deep enteroscopy to achieve gastrostomy access.5 Our group has recently published a technique utilizing endoscopic ultrasonography (EUS) to gain gastrostomy access, but was performed in 2 stages. The procedure was coined EUSdirected transgastric ERCP (EDGE).6 The ideal procedure would be one that can be performed by a single team, with a high technical success rate, in a single session, in a minimally invasive fashion. With the recent Food and Drug Administration approval of a novel, fully covered, lumen-apposing metal stent (AXIOS; XLumena, Mountain View, CA) this procedure is now possible. This case report describes the first entirely endoscopic internal EDGE procedure using a lumenapposing metal stent to create a gastrogastric fistula in a RYGB patient to perform single-session antegrade ERCP.
design serves to prevent leakage. Also the large lumenal diameter of the stent (15 mm) permits for subsequent passage of a therapeutic endoscope. The stent is deployed over a catheter-based delivery system via endoscopic, sonographic, or fluoroscopic guidance. Previous case reports have shown the feasibility of using AXIOS to form cholecystogastrostomy and gastrojejunostomy fistulas.7,8
Video Description This Video describes the case of a 60-year-old woman with a history of RYGB who was admitted for right upper quadrant pain and elevated liver function tests. A magnetic resonance cholangiopancreatography revealed biliary dilation. Therefore, ERCP was planned to evaluate and treat her source of biliary obstruction. After discussion of the various options for obtaining biliary access, the patient agreed to undergo an internal EDGE procedure. The excluded stomach was located sonographically with a linear echoendoscope (GF-UCT180; Olympus, Central Valley, PA) from the remnant gastric pouch and then accessed with a 19-gauge EUS needle (ECHO-19; Cook Medical, Winston-Salem, NC). Contrast along with 120 mL of water was injected through the 19-gauge needle to confirm position within and distend the excluded stomach. Then a 0.035” wire (Hydra Jagwire; Boston Scientific, Natick, MA) was advanced through the needle and coiled within the lumen of the excluded stomach. The gastrogastric fistula tract was dilated with a 4mm balloon (Hurricane RX; Boston Scientific) before advancement of the delivery system of the lumen-apposing metal stent into the excluded stomach. The distal flange was deployed under fluoroscopic and sonographic guidance, and the proximal flange was deployed under endoscopic visualization into the remnant gastric pouch (Figure 1). The lumen of the metal stent was expanded to 18 mm with a dilating balloon (CRE; Boston Scientific). This allowed for antegrade passage of a duodenoscope (TGF-Q180V, Olympus) through the gastrogastric fistula to the major ampulla where ERCP with sphincterotomy; brushing and plastic biliary stent placement were performed in the conventional antegrade route for a distal biliary stricture (Figure 2). However, upon withdrawal the
Description of Technology The AXIOS is a fully covered, braided nitinol metal stent covered with silicone. The design of the stent includes 2 large end flanges measuring 24 mm in diameter, creating tissue apposition in the saddle of the stent. This allows for endoscopic creation of a conduit or fistula between any 2 lumens into which the stent is deployed. The fully covered Gastroenterology 2014;147:566–568
Abbreviations used in this paper: EDGE, EUS-directed transgastric ERCP; ERCP, endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasonography; RYGB, Roux-en-Y gastric bypass. © 2014 by the AGA Institute 0016-5085/$36.00 http://dx.doi.org/10.1053/j.gastro.2014.05.045
GASTROENTEROLOGY IN MOTION Take Home Message
Figure 1. Endoscopic view from the gastric remnant pouch of the lumen-apposing metal stent forming a gastrogastric fistula adjacent to the gastrojejunal anastomosis.
duodenoscope, the metal stent had migrated proximally into the remnant gastric pouch. Therefore, a second lumenapposing metal stent was deployed across the gastrogastric fistula along with 2 intervening 10-Fr plastic double pigtail stents to prevent further migration. The proximally migrated metal stent was removed with a forceps. The total procedure time was 90 minutes. The patient underwent repeat ERCP after 4 weeks through the lumen-apposing metal stent, which revealed resolution of the distal biliary stricture. Therefore the biliary stent along with the gastrogastric lumen apposing metal stent was removed. The remnant gastric pouch fistula was successfully closed with endoscopic suturing. The patient was discharged home directly from the post procedure recovery area.
This is the first known case of performing an internal EDGE procedure using a lumen-apposing metal stent in a RYGB patient. The fact that this procedure was performed in 1 stage, by a single endoscopic team, in a short amount of time, and in a minimally invasive fashion is paramount in terms of clinical and economic impact. Two concerns with this technique include the risk of weight regain while maintaining a gastrogastric fistula for the 4 weeks and the risk of migration. We believe that the risk of weight regain over a short period of time before closure is outweighed by the benefit of the procedure. In addition, the risk of stent migration can be mitigated in future cases by less dilation of the stent and the use of EUS-guided T-fasteners to affix the excluded stomach to the remnant gastric pouch. This lumenapposing stent has important implications and may be the gateway to a new world of interventional endoscopy where bowel-to-bowel anastomosis can be achieved to bypass obstruction, access difficult or distal luminal locations for a variety of therapeutic purposes (ERCP, biopsy, bleeding, etc), and perform bariatric procedures. More refined instruments, prospective studies, and innovative procedures are needed to prove this notion.
Supplementary Material Note: To access the supplementary material accompanying this article, visit the online version of Gastroenterology at www.gastrojournal.org, and at http://dx.doi.org/10.1053/j. gastro.2014.05.045.
References 1.
2.
3.
4.
5.
6. Figure 2. Fluoroscopic image of the lumen apposing metal stent forming a gastrogastric fistula through which a duodenoscope is passed into the excluded stomach.
Wang BCM, Furnback W. Modelling the long-term outcomes of bariatric surgery: a review of cost-effectiveness studies. Best Pract Res Clin Gastroenterol 2013;27: 987–995. Shah RJ, Smolkin M, Yen R, et al. A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video). Gastrointest Endosc 2013;77:593–600. Gutierrez JM, Lederer H, Krook JC, et al. Surgical gastrostomy for pancreatobiliary and duodenal access following Roux en Y gastric bypass. J Gastrointest Surg 2009;13:2170–2175. Schreiner MA, Chang L, Gluck M, et al. Laparoscopyassisted versus balloon enteroscopy-assisted ERCP in bariatric post-Roux-en-Y gastric bypass patients. Gastrointest Endosc 2012;75:748–756. Law R, Song LMWK, Petersen BT, et al. Single-session ERCP in patients with previous Roux-en-Y gastric bypass using percutaneous-assisted transprosthetic endoscopic therapy: a case series. Endoscopy 2013;45: 671–675. Kedia P, Kumta N, Sharaiha R, Kahaleh M. Bypassing the bypass: endoscopic ultrasound-directed transgastric ERCP (EDGE) for Roux-En-Y-anatomy. Gastrointest Endosc 2014 May 15 [Epub ahead of press]. 567
GASTROENTEROLOGY IN MOTION 7.
8.
568
Mönkemüller K, Zabielski M, Didowacz-Grollmann A, et al. Endoluminal transgastric endoscopic anastomosis of the gallbladder using an anchoring self-expanding metal stent. Endoscopy 2013;45(Suppl 2):E164–E166. Itoi T, Itokawa F, Uraoka T, et al. Novel EUS-guided gastrojejunostomy technique using a new doubleballoon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc 2013;78:934–939.
Reprint requests Address requests for reprints to: Michel Kahaleh, MD, AGAF, FACG, FASGE, Chief of Endoscopy, Division of Gastroenterology & Hepatology, Weill Cornell Medical College, 1305 York Avenue, 4th floor, New York, New York 10021. e-mail: [email protected]. Conflicts of interest The authors disclose the following: Michel Kahaleh is a consultant for Boston Scientific and Xlumina, and conducts research for Gore, MI Tech, Pinnacle, and Maunakea.
Internal EUS-Directed Transgastric ERCP (EDGE): Game Over Prashant Kedia, Reem Z. Sharaiha, Nikhil A. Kumta, and Michel Kahaleh Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York
Scan the quick response (QR) code to the left with your mobile device to watch this article’s video abstract and others. Don’t have a QR code reader? Get one by searching ‘QR Scanner’ in your mobile device’s app store.
A
s the prevalence of obesity in the United States exceeds 30%, the number of bariatric procedures being performed, including Roux-en-Y gastric bypass (RYGB), is steadily increasing.1 Therefore, gastroenterologists will inevitably be required to manage pancreaticobiliary diseases in more patients with altered anatomy. Various techniques including deep enteroscopy-assisted endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopy-assisted ERCP have been developed to address the anatomic challenges of these patients. However, they are not without their limitations. Technical success rates of enteroscopy-assisted ERCP have been reported to be as low as 63% in multicenter trials.2 Alternatively, whereas laparoscopy-assisted ERCP has high technical success rates, it carries significant risk of complications and is more costly.3,4 Therefore, efforts by endoscopists have been focused on gaining endoscopic access to the excluded stomach to perform conventional antegrade ERCP. A recently published case series described using deep enteroscopy to achieve gastrostomy access.5 Our group has recently published a technique utilizing endoscopic ultrasonography (EUS) to gain gastrostomy access, but was performed in 2 stages. The procedure was coined EUSdirected transgastric ERCP (EDGE).6 The ideal procedure would be one that can be performed by a single team, with a high technical success rate, in a single session, in a minimally invasive fashion. With the recent Food and Drug Administration approval of a novel, fully covered, lumen-apposing metal stent (AXIOS; XLumena, Mountain View, CA) this procedure is now possible. This case report describes the first entirely endoscopic internal EDGE procedure using a lumenapposing metal stent to create a gastrogastric fistula in a RYGB patient to perform single-session antegrade ERCP.
design serves to prevent leakage. Also the large lumenal diameter of the stent (15 mm) permits for subsequent passage of a therapeutic endoscope. The stent is deployed over a catheter-based delivery system via endoscopic, sonographic, or fluoroscopic guidance. Previous case reports have shown the feasibility of using AXIOS to form cholecystogastrostomy and gastrojejunostomy fistulas.7,8
Video Description This Video describes the case of a 60-year-old woman with a history of RYGB who was admitted for right upper quadrant pain and elevated liver function tests. A magnetic resonance cholangiopancreatography revealed biliary dilation. Therefore, ERCP was planned to evaluate and treat her source of biliary obstruction. After discussion of the various options for obtaining biliary access, the patient agreed to undergo an internal EDGE procedure. The excluded stomach was located sonographically with a linear echoendoscope (GF-UCT180; Olympus, Central Valley, PA) from the remnant gastric pouch and then accessed with a 19-gauge EUS needle (ECHO-19; Cook Medical, Winston-Salem, NC). Contrast along with 120 mL of water was injected through the 19-gauge needle to confirm position within and distend the excluded stomach. Then a 0.035” wire (Hydra Jagwire; Boston Scientific, Natick, MA) was advanced through the needle and coiled within the lumen of the excluded stomach. The gastrogastric fistula tract was dilated with a 4mm balloon (Hurricane RX; Boston Scientific) before advancement of the delivery system of the lumen-apposing metal stent into the excluded stomach. The distal flange was deployed under fluoroscopic and sonographic guidance, and the proximal flange was deployed under endoscopic visualization into the remnant gastric pouch (Figure 1). The lumen of the metal stent was expanded to 18 mm with a dilating balloon (CRE; Boston Scientific). This allowed for antegrade passage of a duodenoscope (TGF-Q180V, Olympus) through the gastrogastric fistula to the major ampulla where ERCP with sphincterotomy; brushing and plastic biliary stent placement were performed in the conventional antegrade route for a distal biliary stricture (Figure 2). However, upon withdrawal the
Description of Technology The AXIOS is a fully covered, braided nitinol metal stent covered with silicone. The design of the stent includes 2 large end flanges measuring 24 mm in diameter, creating tissue apposition in the saddle of the stent. This allows for endoscopic creation of a conduit or fistula between any 2 lumens into which the stent is deployed. The fully covered Gastroenterology 2014;147:566–568
Abbreviations used in this paper: EDGE, EUS-directed transgastric ERCP; ERCP, endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasonography; RYGB, Roux-en-Y gastric bypass. © 2014 by the AGA Institute 0016-5085/$36.00 http://dx.doi.org/10.1053/j.gastro.2014.05.045
GASTROENTEROLOGY IN MOTION Take Home Message
Figure 1. Endoscopic view from the gastric remnant pouch of the lumen-apposing metal stent forming a gastrogastric fistula adjacent to the gastrojejunal anastomosis.
duodenoscope, the metal stent had migrated proximally into the remnant gastric pouch. Therefore, a second lumenapposing metal stent was deployed across the gastrogastric fistula along with 2 intervening 10-Fr plastic double pigtail stents to prevent further migration. The proximally migrated metal stent was removed with a forceps. The total procedure time was 90 minutes. The patient underwent repeat ERCP after 4 weeks through the lumen-apposing metal stent, which revealed resolution of the distal biliary stricture. Therefore the biliary stent along with the gastrogastric lumen apposing metal stent was removed. The remnant gastric pouch fistula was successfully closed with endoscopic suturing. The patient was discharged home directly from the post procedure recovery area.
This is the first known case of performing an internal EDGE procedure using a lumen-apposing metal stent in a RYGB patient. The fact that this procedure was performed in 1 stage, by a single endoscopic team, in a short amount of time, and in a minimally invasive fashion is paramount in terms of clinical and economic impact. Two concerns with this technique include the risk of weight regain while maintaining a gastrogastric fistula for the 4 weeks and the risk of migration. We believe that the risk of weight regain over a short period of time before closure is outweighed by the benefit of the procedure. In addition, the risk of stent migration can be mitigated in future cases by less dilation of the stent and the use of EUS-guided T-fasteners to affix the excluded stomach to the remnant gastric pouch. This lumenapposing stent has important implications and may be the gateway to a new world of interventional endoscopy where bowel-to-bowel anastomosis can be achieved to bypass obstruction, access difficult or distal luminal locations for a variety of therapeutic purposes (ERCP, biopsy, bleeding, etc), and perform bariatric procedures. More refined instruments, prospective studies, and innovative procedures are needed to prove this notion.
Supplementary Material Note: To access the supplementary material accompanying this article, visit the online version of Gastroenterology at www.gastrojournal.org, and at http://dx.doi.org/10.1053/j. gastro.2014.05.045.
References 1.
2.
3.
4.
5.
6. Figure 2. Fluoroscopic image of the lumen apposing metal stent forming a gastrogastric fistula through which a duodenoscope is passed into the excluded stomach.
Wang BCM, Furnback W. Modelling the long-term outcomes of bariatric surgery: a review of cost-effectiveness studies. Best Pract Res Clin Gastroenterol 2013;27: 987–995. Shah RJ, Smolkin M, Yen R, et al. A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video). Gastrointest Endosc 2013;77:593–600. Gutierrez JM, Lederer H, Krook JC, et al. Surgical gastrostomy for pancreatobiliary and duodenal access following Roux en Y gastric bypass. J Gastrointest Surg 2009;13:2170–2175. Schreiner MA, Chang L, Gluck M, et al. Laparoscopyassisted versus balloon enteroscopy-assisted ERCP in bariatric post-Roux-en-Y gastric bypass patients. Gastrointest Endosc 2012;75:748–756. Law R, Song LMWK, Petersen BT, et al. Single-session ERCP in patients with previous Roux-en-Y gastric bypass using percutaneous-assisted transprosthetic endoscopic therapy: a case series. Endoscopy 2013;45: 671–675. Kedia P, Kumta N, Sharaiha R, Kahaleh M. Bypassing the bypass: endoscopic ultrasound-directed transgastric ERCP (EDGE) for Roux-En-Y-anatomy. Gastrointest Endosc 2014 May 15 [Epub ahead of press]. 567
GASTROENTEROLOGY IN MOTION 7.
8.
568
Mönkemüller K, Zabielski M, Didowacz-Grollmann A, et al. Endoluminal transgastric endoscopic anastomosis of the gallbladder using an anchoring self-expanding metal stent. Endoscopy 2013;45(Suppl 2):E164–E166. Itoi T, Itokawa F, Uraoka T, et al. Novel EUS-guided gastrojejunostomy technique using a new doubleballoon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc 2013;78:934–939.
Reprint requests Address requests for reprints to: Michel Kahaleh, MD, AGAF, FACG, FASGE, Chief of Endoscopy, Division of Gastroenterology & Hepatology, Weill Cornell Medical College, 1305 York Avenue, 4th floor, New York, New York 10021. e-mail: [email protected]. Conflicts of interest The authors disclose the following: Michel Kahaleh is a consultant for Boston Scientific and Xlumina, and conducts research for Gore, MI Tech, Pinnacle, and Maunakea.