Endoscopic ultrasound-directed transgastric ERCP (EDGE): A multicenter US study on long-term follow-up and fistula closure

Abstract

Background and study aims Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a safe and efficacious procedure to treat pancreaticobiliary diseases in Roux-en-Y gastric bypass (RYGB). This multicenter study aimed to determine the long-term outcomes of EDGE focusing on fistula persistence rates and post-procedure weight change.

Patients and methods Information about patients with Roux-en-Y gastric bypass anatomy who underwent EDGE between 2015 and 2021 from 10 institutions was captured in a registry. Patient demographics, procedural details, and clinical outcomes were analyzed.

Results One hundred seventy-two patients were included in the study (mean age 60, 25 % male). Technical success of lumen-apposing metal stent (LAMS) placement was 171 of 172 (99.4 %) while clinical success of intervention was 95%. The mean procedure time was 65 minutes. The most commonly reported complication was stent dislodgement/migration (n = 29, 17). Mean length of time of LAMS duration was 69 days. Mean follow-up time was 6 months. Endoscopic fistula closure was performed in 40 % of patients (69/172) at the time of LAMS removal. Persistence of fistula was observed in 19 of 62 patients (31 %) assessed. Length of LAMS indwell time (days) was a predictor of persistent fistula. The average weight gain while the LAMS was in place was 12 lb in 63 patients (36.6 %); 59.4 % of patients gained < 5 lb.

Conclusions EDGE is a safe and efficacious procedure for RYGB patients requiring ERCP. Post-procedure evaluation and management of the enteral fistula varies widely among centers currently and would benefit from further standardization. Fistula persistence appears to be uncommon and can be managed endoscopically but may be related to length of indwell times of the LAMS.

Publication History

Received: 08 September 2022

Accepted after revision: 09 March 2023

Article published online:
26 May 2023

• References

• 1 Hales CM, Carroll MD, Fryar CD. et al. Prevalence of obesity and severe obesity among adults: United States, 2017-2018. NCHS Data Brief 2020; 360: 1-8
• 2 English WJ, DeMaria EJ, Hutter MM. et al. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis 2020; 16: 457-463
• 3 Shiffman ML, Sugerman HJ, Kellum JM. et al. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology 1992; 103: 214-221
• 4 Nagem RG, Lázaro-da-Silva A, de Oliveira RM. et al. Gallstone-related complications after Roux-en-Y gastric bypass: a prospective study. Hepatobiliary Pancreat Dis Int 2012; 11: 630-635
• 5 Uy MC, Talingdan-Te MC, Espinosa WZ. et al. Ursodeoxycholic acid in the prevention of gallstone formation after bariatric surgery: a meta-analysis. Obes Surg 2008; 18: 1532-1538
• 6 Miller K, Hell E, Lang B. et al. Gallstone formation prophylaxis after gastric restrictive procedures for weight loss: a randomized double-blind placebo-controlled trial. Ann Surg 2003; 238: 697-702
• 7 Kedia P, Sharaiha RZ, Kumta NA. et al. Internal EUS-directed transgastric ERCP (EDGE): game over. Gastroenterology 2014; 147: 566-568
• 8 Runge TM, Kowalski TE, Baron TH. et al. 1026 Living on the edge - success, long-term complications, and implications following EUS-directed transgastric ERCP: a multicenter study. Gastrointest Endosc 2019; 89: AB131
• 9 Tyberg A, Nieto J, Salgado S. et al. Endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography or EUS: Mid-term analysis of an emerging procedure. Clin Endosc 2017; 50: 185-190
• 10 Ngamruengphong S, Nieto J, Kunda R. et al. Endoscopic ultrasound-guided creation of a transgastric fistula for the management of hepatobiliary disease in patients with Roux-en-Y gastric bypass. Endoscopy 2017; 49: 549-552
• 11 James TW, Baron TH. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a single-center US experience with follow-up data on fistula closure. Obes Surg 2019; 29: 451-456
• 12 Wang TJ, Thompson CC, Ryou M. Gastric access temporary for endoscopy (GATE): a proposed algorithm for EUS-directed transgastric ERCP in gastric bypass patients. Surg Endosc 2019; 33: 2024-2033
• 13 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 14 Hintze RE, Adler A, Veltzke W. et al. Endoscopic access to the papilla of Vater for endoscopic retrograde cholangiopancreatography in patients with billroth II or Roux-en-Y gastrojejunostomy. Endoscopy 1997; 29: 69-73
• 15 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
• 16 Banerjee N, Parepally M, Byrne TK. et al. Systematic review of transgastric ERCP in Roux-en-Y gastric bypass patients. Surg Obes Relat Dis 2017; 13: 1236-1242
• 17 Baron TH, Song LM, Ferreira LE. et al. Novel approach to therapeutic ERCP after long-limb Roux-en-Y gastric bypass surgery using transgastric self-expandable metal stents: experimental outcomes and first human case study (with videos). Gastrointest Endosc 2012; 75: 1258-1263
• 18 Prakash S, Elmunzer BJ, Forster EM. et al. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a systematic review describing the outcomes, adverse events, and knowledge gaps. Endoscopy 2022; 54: 52-61
• 19 Bukhari M, Kowalski T, Nieto J. et al. An international, multicenter, comparative trial of EUS-guided gastrogastrostomy-assisted ERCP versus enteroscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Gastrointest Endosc 2018; 88: 486-494
• 20 Kedia P, Tarnasky PR, Nieto J. et al. 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. J Clin Gastroenterol 2019; 53: 304-308
• 21 Kedia P, Tyberg A, Kumta NA. et al. EUS-directed transgastric ERCP for Roux-en-Y gastric bypass anatomy: a minimally invasive approach. Gastrointest Endosc 2015; 82: 560-565
• 22 Krafft MR, Hsueh W, James TW. et al. The EDGI new take on EDGE: EUS-directed transgastric intervention (EDGI), other than ERCP, for Roux-en-Y gastric bypass anatomy: a multicenter study. Endosc Int Open 2019; 7: E1231-E1240
• 23 Nylund K, Hausken T, Ødegaard S. et al. Gastrointestinal wall thickness measured with transabdominal ultrasonography and its relationship to demographic factors in healthy subjects. Ultraschall Med 2012; 33: E225-E232 DOI: 10.1055/s-0031-1299329.
• 24 Shinn B, Boortalary T, Raijman I. et al. Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration. Gastrointest Endosc 2021; 94: 727-732
• 25 Runge TM, Chiang AL, Kowalski TE. et al. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study. Endoscopy 2021; 53: 611-618
• 26 Krafft MR, Lorenze A, Croglio MP. et al. "Innocent as a LAMS": Does spontaneous fistula closure (secondary intention), after EUS-directed transgastric ERCP (EDGE) via 20-mm lumen-apposing metal stent, confer an increased risk of persistent fistula and unintentional weight gain?. Dig Dis Sci 2022; 67: 2337-2346
• 27 Fernandez-Esparrach G, Lautz DB, Thompson CC. Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. Surg Obes Relat Dis 2010; 6: 282-288
• 28 Mukewar S, Kumar N, Catalano M. et al. Safety and efficacy of fistula closure by endoscopic suturing: a multi-center study. Endoscopy 2016; 48: 1023-1028
• 29 Parvataneni S, Kumar V, Confer B. et al. EUS-directed transgastric ERCP (EDGE) versus laparoscopy-assisted ERCP (LAERCP) for Roux-en-Y gastric bypass (RYGB): A single center experience: 917. Am J Gastroenterol 2019; 114: S536