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%.
