The Capability of a Novel All-in-One Sphincterotome With High Rotation and a Freely Bendable Blade for Various Endoscopic Retrograde Cholangiopancreatography-Related Procedures.

Objectives: We aimed to evaluate the capability of a novel all-in-one sphincterotome in various procedures related to endoscopic retrograde cholangiopancreatography (ERCP), including procedures in patients with surgically altered anatomy. Methods: A total of 108 patients who underwent ERCP using the novel all-in-one sphincterotome (ENGETSU; Kaneka Medix, Tokyo, Japan) between November 2023 and December 2024 were included in this retrospective analysis. We evaluated the success rates of bile duct cannulation and endoscopic sphincterotomy (EST) as well as the incidence of procedure-related adverse events (AEs). Results: Bile duct cannulation was performed in patients with native papillae, including 30 patients with normal anatomy, three with Billroth I reconstruction, one with Billroth II reconstruction, and six with Roux-en-Y reconstruction. The overall cannulation success rate was 72.5%, with a median cannulation time of 3 min. EST was performed in 65 patients with normal anatomy, three with Billroth I reconstruction, and 13 with Roux-en-Y reconstruction, with an overall success rate of 98.8%. Procedure-related AEs were observed in four patients with post-ERCP pancreatitis, three with post-EST bleeding, and one with cholangitis; all patients recovered and were discharged. Among 14 patients in whom deep biliary cannulation failed when using the conventional ERCP cannula, subsequent use of the novel device during second-line cannulation led to successful cannulation in 13 patients (92.9%). Conclusion: The novel all-in-one sphincterotome demonstrated the capability to perform various ERCP-related procedures, including in patients with surgically altered anatomy. Trial Registration: UMIN000058337.