Efficacy and Safety of a Novel Rotatable Sphincterotome for Endoscopic Sphincterotomy in Patients With Roux-en-Y Gastrectomy During Balloon Enteroscopy-Assisted ERCP (With Video).

Endoscopic sphincterotomy (EST) is challenging for patients with surgically altered anatomy (SAA). The blades of conventional sphincterotomes designed for SAA do not always face the correct direction of EST. We aimed to evaluate the efficacy and safety of a novel rotatable sphincterotome for EST in patients undergoing Roux-en-Y gastrectomy during balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP). Patients with Roux-en-Y gastrectomy who underwent BE-ERCP and EST using a novel rotatable sphincterotome between April 2024 and February 2025 were analyzed. Overall, 30 patients were attempted EST with a novel rotatable sphincterotome. EST, including adjustment of the blade to the correct incision direction, was successfully performed in all patients. The median time to complete EST was 3 min. Adverse events occurred in one case of mild post-ERCP pancreatitis. There was no bleeding or perforation associated with EST. No significant differences were observed in the success rate of EST, time to complete EST, or adverse event rate between the experienced endoscopists and trainee fellows. The use of a novel rotatable sphincterotome for EST during BE-ERCP was technically feasible and safe in patients who underwent Roux-en-Y gastrectomy, which may help standardize EST in patients with SAA.