Outcomes of a Physician-Controlled Wire-Guided Cannulation of the Bile Duct Using a Novel Sphincterotome: A Single-Center, Prospective Study.

Background: Efficacy of a physician-controlled wire-guided cannulation of the bile duct has been reported. This study aimed to evaluate a novel sphincterotome with a short tip and a short wire, which can be bowed compactly compared to conventional sphincterotomes.

Methods: This was a single-arm, single-center, prospective study. We enrolled patients with choledocholithiasis and/or obstructive jaundice and/or cholangitis for whom endoscopic sphincterotomy was planned. The main outcome measurement was the proportion of successful selective bile duct cannulation by physician-controlled wire-guided cannulation within 10 min.

Results: The study cohort consisted of 40 patients. The proportion of successful selective bile duct cannulation within 10 min was 72.5% (n = 29). The proportion of post-endoscopic retrograde cholangiopancreatography pancreatitis was 2.5% (mild, n = 1) and the proportion of hemorrhage was 2.5% (moderate, n = 1).

Conclusions: Although physician-controlled wire-guided cannulation using a novel sphincterotome with a short tip and a short wire was not superior to wire-guided cannulation using conventional sphincterotomes reported in a previous study, it remains a safe and efficacious alternative in terms of successful biliary cannulation.