Abstract
INTRODUCTION: ERCP can be difficult in patients with Roux-En-Y foregut anatomy due to difficulty accessing the papilla, where balloon-assisted enteroscopy or laparoscopy based access has been used. Endoscopic ultrasound directed trans-gastric ERCP (EDGE) allows access to the excluded stomach via a lumen apposing metal stent (LAMS) from the gastric pouch, and passage of the duodenoscope in standard anatomical fashion. Early studies demonstrated high technical and clinical success rates of EDGE with few major adverse events (AEs). We aimed at describing rates of technical and clinical success and AEs of EDGE, impact on patients’ weight and incidence of persistent gastro-gastric fistulae (GGF). METHODS: This is a single center retrospective analysis of a prospectively collected database. All patients who underwent EDGE from 06/2018 to 05/2019 were included. AEs were defined per ASGE lexicon. Descriptive statistical analysis was used to assess outcomes. RESULTS: Nineteen patients were included in the study [mean age 59.4 years (SD = 10.7); 79% females, Table 1]. Two additional patients with spontaneous GGF noted at planned EDGE had no LAMS placed and were excluded. Choledocholithiasis was the most common indication (7/19, 37%), with three associated with cholangitis. Technical success for EUS guided LAMS placement/GGF creation was 100% (Hot AXIOS, 15 mm × 10 mm) with a mean procedure time of 26.8 (SD = 10) minutes and no major AEs. Same session ERCP was done in 2/19 (10%) with LAMS anchoring and 17/29 ERCPs (90%) performed a mean 5.5 (SD = 4.9) days after LAMS placement with a diagnostic duodenoscope (18/19, 95%) most commonly used. Mean ERCP time was 38.7 (SD = 4.9) min with a technical and clinical success of 95% (18/19). Two ERCP-related moderate adverse events occurred managed endoscopically and conservatively. LAMS were removed within 4 weeks of last ERCP, with APC +/- endoscopic suturing in 13/16 (81%) with 100% technical success of endoscopic closure. There was no weight gain noted on a mean follow up of 11.3(SD = 9) weeks. GGF resolution was confirmed in 5/16 with CT (1/5), Upper GI Series (2/5) or upper endoscopy (2/5) done in 6 months of GGF closure with other patients yet to reach the 6-month time-frame (Table 2). CONCLUSION: EDGE is an effective procedure for patients with Roux-en-Y foregut anatomy, with acceptable safety profile and low risk of persistent GGF or weight gain in this series. Further prospective studies are needed to assess the long-term safety, in regards to weight gain and persistence of GGF.
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