EUS-Directed Transgastric ERCP (EDGE): A Retrospective, Multicenter Study.

Background and Study Aims: Endoscopic ultrasound-directed transgastric ERCP (EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. Aims of this study were 1) to determine rates of long-term adverse events (AEs) after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; 2) identify predictors of persistent fistula; 3) assess outcomes of endoscopic closure when persistent fistula is encountered. Patients and Methods: This was a multicenter, retrospective study involving 13 centers between 1/2014 and 3/2019. AEs were defined according to ASGE lexicon. Persistent fistula was defined as upper GI series or EGD showing evidence of fistula. Results: A total of 178 patients (mean age 58 years, 79% F) underwent EDGE. Technical success was achieved in 98% of cases (175/178) with a mean procedure time of 92 min. Periprocedural AEs occurred in 28 patients (15.7%; mild 10.1%, moderate 3.3%, severe 2.2%). The 4 severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10% of those sent for objective testing (9/90). Following identification of fistula, 5/9 patients underwent endoscopic closure procedures, which were successful in all cases. Conclusions: The EDGE procedure is associated with high clinical success rates, and an acceptable risk profile. Persistent fistula after lumen apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistula are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.