Endoscopic Ultrasound-Directed Transgastric ERCP in Patients With Roux-En-Y Gastric Bypass: A Multicenter Prospective Cohort Study (EDGE-Pilot).

Objectives: Endoscopic retrograde cholangiopancreatography (ERCP) is frequently indicated in patients who underwent Roux-en-Y gastric bypass (RYGB) surgery. Endoscopic ultrasound-directed ERCP (EDGE) is a technique that is 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. However, prospective studies on EDGE are lacking. The aim of this study is to provide prospective evidence for the efficacy and safety of EDGE, including fistula closure.

Methods: This multicenter prospective cohort study included patients scheduled for elective ERCP after RYGB surgery. EDGE was performed as a two-step procedure. The primary endpoint was overall technical success. Secondary endpoints were the technical success of LAMS placement and ERCP individually, persistent fistula, and adverse events (AEs).

Results: Between January 2021 and August 2024, 26 patients were included in four 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 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 (0/24). No mortality occurred.

Conclusions: 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%).