Endoscopic Ultrasound-Directed TransGastric ERCP in patients with Roux-en-Y gastric bypass: a multicenter prospective cohort study (EDGE-pilot)

Aims Endoscopic retrograde cholangiopancreatography (ERCP) is increasingly indicated in patients who underwent Roux-en-Y gastric bypass surgery (RYGB). However, due to the altered anatomy, it is challenging to gain pancreatobiliary access in patients after creation of 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, risks of laparoscopic surgery and high costs. Endoscopic ultrasound directed ERCP (EDGE) is a relatively new technique which exist of creation of a gastro-gastrostomy using a lumen apposing metal stent (LAMS) between the gastric pouch and the excluded stomach, facilitating subsequent ERCPs. Although EDGE gained more popularity over the last few years, prospective studies are lacking. The aim of this study is to provide evidence for the efficacy and safety, including closure of the fistula, of EDGE in patients with an indication for ERCP after RYGB.

Methods This multicenter prospective cohort study included all consecutive patients scheduled for elective ERCP after RYGB surgery. Patients were excluded if they required a laparoscopic cholecystectomy. EDGE was performed as a 2-step procedure to minimize the risk of stent dislodgement. The primary endpoint was technical success. Secondary endpoints were technical success of each step individually, clinical success, fistula closure during follow-up, procedure-related adverse events (AEs), technical failure and total procedure time.

Results Between January 2021 and August 2024, 27 patients (23 female [85.2%], median age 58 years [IQR 45 – 64] were included in 4 Dutch hospitals. Median follow-up duration was 140 days [IQR 61 – 206]. Mean BMI was 28.59 (SD 5.02). Indications for EDGE were choledocholithiasis (n=23), (presumed) malignant biliary obstruction (n=3) and iatrogenic bile injury (n=1). Technical success for EDGE step 1 was achieved in all patients. Technical success for ERCP through LAMS (step 2) was achieved in 27/28 patients (96%). In one patient no ERCP was performed due to complications and a PTC-drain was placed. Median LAMS indwelling time was 15 days [IQR 11 – 25 days]. Procedure-related AEs occurred in 5 patients (18.5%). Two AEs were EDGE related (7.4%): one patient suffered a contralateral duodenal wall perforation following scope intubation and stent dislodgment occurred in another patient for which an endoscopic re-intervention was successfully performed. The remaining three AEs were ERCP related: in one patient a post-procedural bleeding occurred, in one patient a CBD perforation occurred, and one patient suffered from post-ERCP pancreatitis. Eight patients were lost to follow-up. In all remaining patients (19/19), there was either endoscopic or radiological evidence of a closed fistula.

Conclusions This prospective study shows that EDGE is a feasible procedure with high technical success, and with a 100% fistula closure rate. However, EDGE-related AEs occurred in 7.4%.

Publication History

Article published online:
27 March 2025