Introduction
Endoscopic retrograde cholangiopancreatography (ERCP) is frequently indicated in patients who underwent Roux-en-Y gastric bypass (RYGB) surgery. (1, 2) However, due to the altered anatomy, it is challenging to gain pancreatobiliary access in patients following a RYGB. Several strategies are currently available, but all have their disadvantages. Laparoscopy-assisted ERCP (LA-ERCP), the current golden standard, has higher success rates but also comes with logistical challenges of intraoperative ERCP, peri-operative complications and high costs. (3 - 5) Endoscopic ultrasound directed ERCP (EDGE) is a technique used to create a gastro-gastrostomy by placing a lumen apposing metal stent (LAMS) between the gastric pouch and the excluded stomach, facilitating subsequent ERCP.(6) Although EDGE gained more popularity over the last few years, prospective studies are lacking.
Aims & Methods
The aim of this study is to provide prospective evidence for the efficacy and safety of EDGE, including fistula closure.This multicentre prospective cohort study included all consecutive patients scheduled for elective ERCP after RYGB surgery. EDGE was performed as a two-step procedure. Primary endpoint was overall technical success. Secondary endpoints were technical success of LAMS placement and ERCP individually, persistent fistula and other procedure-related adverse events (AEs).
Results
Between January 2021 and August 2024, 26 patients were included in 4 Dutch hospitals. Overall technical success was achieved in 25/26 patients (96.2%). Median LAMS indwelling time was 14 days [IQR 11 – 28 days]. Two EDGE-related AEs occurred (7.7%); one perforation of the contralateral duodenal wall following scope insertion and one bleeding after LAMS placement. Two ERCP-related AEs occurred (7.7%): one CBD perforation and one post-ERCP pancreatitis. Two patients were lost to follow-up. None of the remaining patients had a persistent fistula, based on radiologic or endoscopic evidence (0/24). No mortality occurred.
| Variable | Total (n = 26) |
| Overall technical success, n (%) | 25 (96.2) |
| Overall clinical success, n (%) | 25 (96.2) |
Persistent fistula (n (%)
| 0 (0.0) |
EDGE-related adverse events, n (%)
Stent dislodgment
Stent dysfunction
Bleeding
Perforation duodenal wall
|
0 (0.0)
0 (0.0)
1 (3.8)
1 (3.8)
|
ERCP-related adverse events, n (%)
Perforation common bile duct
Post-ERCP pancreatitis
Bleeding
| 1 (3.8)
1 (3.8)
0 (0.0) |
Severity of adverse events
Grade I
Grade II
Grade IIIa
Grade IVb | 0 (0.0)
2 (7.7)
1 (3.8)
1 (3.8) |
| Mortality, n (%) | 0 (0.0) |
| Hospital stay, days (IQR) | 1 (0 - 2) |
Conclusion
This prospective study shows that two-step EDGE is relatively safe and associated with high technical success, without any cases of a persistent fistula. However, AEs occurred in 4 patients (15.4%), of which two were EDGE-related (7.7%).
References
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2. Haal S, Guman MSS, Boerlage TCC, Acherman YIZ, de Brauw LM, Bruin S, et al. Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial. Lancet Gastroenterol Hepatol. 2021;6(12):993-1001.
3. Gangwani MK, Aziz M, Haghbin H, Iqbal A, Dillard J, Dahiya DS, et al. Comparing EUS-directed Transgastric ERCP (EDGE) Versus Laparoscopic-Assisted ERCP Versus Enteroscopic ERCP: A Network Meta-analysis. J Clin Gastroenterol. 2024;58(2):110-9.
4. da Ponte-Neto AM, Bernardo WM, de ACLM, Josino IR, Brunaldi VO, Moura DTH, et al. Comparison between Enteroscopy-Based and Laparoscopy-Assisted ERCP for Accessing the Biliary Tree in Patients with Roux-en-Y Gastric Bypass: Systematic Review and Meta-analysis. Obes Surg. 2018;28(12):4064-76.
5. Abbas AM, Strong AT, Diehl DL, Brauer BC, Lee IH, Burbridge R, et al. Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass. Gastrointestinal endoscopy. 2018;87(4):1031-9.
6. van Wanrooij RLJ, Bronswijk M, Kunda R, Everett SM, Lakhtakia S, Rimbas M, et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2022;54(3):310-32.
