EUS-directed Transgastric ERCP (EDGE) Versus Laparoscopy-assisted ERCP (LA-ERCP) for Roux-en-Y Gastric Bypass (RYGB) Anatomy A Multicenter Early Comparative Experience of Clinical Outcomes Prashant Kedia, MD,* Paul R. Tarnasky, MD,* Jose Nieto, MD,† Stephen L. Steele, MD,* Ali Siddiqui, MD,‡ Ming-ming Xu, MD,§ Amy Tyberg, MD,ǁ Monica Gaidhane, MD,ǁ and Michel Kahaleh, MD, AGAF, FACG, FASGEǁ Background and Aims: The standard of care for managing pan- creaticobiliary disease in altered Roux-en-Y gastric bypass patients is laparoscopy-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP), but is limited by cost and adverse events. Recently a minimally invasive, completely endoscopic approach using endoscopic ultrasound (EUS) directed transgastric ERCP (EDGE) has been described. We aim to compare EDGE to LA-ERCP in this study. Methods: Patients from May 2005 to June 2017 with Roux-en-Y gastric bypass anatomy having undergone LA-ERCP or EDGE at 4 tertiary centers were captured in a registry. Patient demographics, procedural details, and clinical outcomes were measured for each group. Results: Seventy-two patients (n = 29 EDGE, n = 43 LA-ERCP) were included in this study. There was no significant difference in the technical success of EDGE gastrogastric fistula (96.5%) versus LA-gastrostomy creation (100%). The success rate of achieving therapeutic ERCP (EDGE 96.5% vs. LA-ERCP 97.7%) and number of ERCP (EDGE 1.2 vs. LA-ERCP 1.02) needed to achieve clinical resolution was similar between both groups. Adverse event rate for EDGE, 24% (7/29) and LA-ERCP, 19% (8/43) was similar. The total procedure time (73 vs. 184 min) and length of hospital stay (0.8 vs. 2.65 d) was significantly shorter for EDGE compared to LA-ERCP. The overall weight change after EDGE was -6.6 lbs at an average 28-week follow-up. Conclusions: This study suggests that the EDGE procedure has similar technical success and adverse events compared with LA- ERCP with the benefit of significantly shorter procedure times and hospital stay. EDGE may offer a minimally invasive, effective option, with less resource utilization, and without significant weight gain. Key Words: EDGE, ERCP, LA-ERCP, Roux-en-Y, gastric bypass, biliary stricture, endoscopic retrograde cholangiopancreatography, laparoscopy, laparoscopy-assisted (J Clin Gastroenterol 2018;00:000–000) G astroenterologists are frequently encountered by the challenge of managing pancreaticobiliary disease in Roux-en-Y gastric bypass (RYGB) anatomy. Obesity’s effects on lipid and hormone metabolism, along with gall- bladder motility, can increase the formation of gallstones. 1 Up to 30% of postbariatric patients may develop gallstones 24 months after their surgery in the setting of significant weight loss. 2,3 The standard of care for biliary access in these patients is laparoscopy-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP) due to its high tech- nical success rates. 4 However, LA-ERCP is limited by the need to coordinate multiple specialty teams to perform the procedure along with significant potential complications. Case series and multicenter analyses have reported adverse event rates up to 36% with conversion to open gastrostomy in 13% of patients. 4–7 Recently a novel, completely endoscopic approach using endoscopic ultrasound (EUS) to create a gastrogastric or jejunogastric fistula, using a lumen-apposing metal stent (LAMS), through which a conventional ERCP can be performed using a standard duodenoscope has been described. 8 The benefits of EUS-directed transgastric ERCP (EDGE) include being minimally invasive and performed by a single team. Early reported outcomes of this emerging tech- nique are encouraging given its high technical success rates, limited complications and lack of patient weight gain. 9 However, no studies have yet to compare EDGE to the Received for publication October 25, 2017; accepted March 5, 2018. From the *Department of Gastroenterology, Methodist Dallas Medical Center, Dallas, TX; †Advanced Therapeutic Endoscopy Center, Borland Groover Clinic, Jacksonville, FL; ‡Department of Gas- troenterology, Thomas Jefferson, Philadelphia, PA; §Weill Cornell Medical Center, New York, NY; and ǁRutgers Robert Wood Johnson, New Brunswick, NJ. ClinicalTrials.gov Identifier: NCT01522573. P.K., A.T., A.S., P.R.T., M.-m.X, J.N., and S.L.S.: acquisition of data, drafting of the manuscript, critical revision of the manuscript for important intellectual content. M.G.: acquisition of data, inter- pretation of data, critical revision of the manuscript for important intellectual content, study coordination. M.K.: study concept and design, acquisition of data, critical revision of the manuscript for important intellectual content, study supervision. M.K.: received grant support from Boston Scientific, Fujinon, EMcison, Xlumena Inc., W.L. Gore, MaunaKea, Apollo Endosurgery, Cook Endoscopy, ASPIRE Bariatrics, GI Dynamics, NinePoint Medical, Merit Medical, Olympus and MI Tech. He is a consultant for Boston Scientific, Xlumena Inc., Concordia Laboratories Inc., ABBvie, and MaunaKea Tech. P.K.: consultant for Boston Scien- tific, Endogastric solutions and Apollo Endosurgery. A.S.: con- sultant for Boston Scientific, Cook Endoscopy and Medtronic. He has received research grant support from Boston Scientific and Medtronic. He is a speaker for ABBVIE. P.R.T.: consultant for Boston Scientific. A.T.: consultant for EndoGastric Solutions. The remaining authors declare that they have nothing to disclose. Address correspondence to: Michel Kahaleh, MD, AGAF, FACG, FASGE, Department of Medicine Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901 (e-mail: mkahaleh@gmail.com). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MCG.0000000000001037 ORIGINAL ARTICLE J Clin Gastroenterol  Volume 00, Number 00, ’’ 2018 www.jcge.com | 1 Copyright r 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. This paper can be cited using the date of access and the unique DOI number which can be found in the footnotes.