Enteroscopy-assisted ERCP in patients with surgically altered anatomy: Multicenter prospective registry (SAMISEN-B) using motorized spiral enteroscopy

<b>Background and study aims</b> This was a prospective study of efficacy and safety of motorized spiral enteroscopy (MSE) to perform biliary endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy at five European centers. <b>Patients and methods</b> Consecutive patients with biliary indications for enteroscopy-assisted ERCP were enrolled. Objectives were technical success, adverse event (AE) rate, and patient radiation exposure. <b>Results</b> Eighty-nine patients were enrolled and one was excluded for a pancreatic indication. All participants had variations of Billroth II reconstruction (29.5%) or Roux-en-Y reconstruction (70.5%), either with naive papilla (39%) or hepaticojejunostomy (61%). Main indications were anastomotic stricture treatment and/or biliary stone removal. Enteroscopy to reach the bile duct was possible in 65 of 88 patients (74%), bile duct cannulation in 54 of 88 (61%), and therapeutic ERCP was technically successful in 48 of 88 (54%). In Billroth II variations, technical success was achieved in 13 of 26 patients (50%) compared with 35 of 62 (57%, <i>P</i> = 0.5792 Chi square) in Roux-en-Y reconstructions (including bariatric gastric bypass). ERCP with intact papilla was successful in 17 of 34 patients (50%) compared with 31 of 54 (57%, <i>P</i> = 0.4968 Chi square) in hepaticojejunostomy. The study was prematurely terminated July 2023 because MSE was withdrawn by the manufacturer for safety issues. Overall, in 12 of 88 patients (14%), AEs were recorded and six (7%) were considered serious. Only one serious AE was attributable to MSE enteroscopy: perforation of the proximal esophagus during enteroscope insertion. <b>Conclusions</b> This prospective multicenter study was prematurely discontinued due to withdrawal of the MSE by the manufacturer because of safety issues. Technical success of MSE-assisted biliary ERCP in different types of surgically altered anatomy was 54%, which was lower than anticipated. There was one esophageal perforation attributable to use of MSE. (clinicaltrials.gov: NCT05129449).