Dome vs tapered tip sphincterotomes in endoscopic retrograde cholangiopancreatography: A pilot study on cannulation success and postprocedural pancreatitis.

Background: Despite advancements, endoscopic retrograde cholangiopancreatography (ERCP) poses challenges, including the risk of post-ERCP pancreatitis and difficulty of biliary cannulation.

Aim: To compare dome and tapered tip sphincterotomes, focusing on their efficacy in achieving successful biliary cannulation and reducing the incidence of post-ERCP pancreatitis.

Methods: In this prospective, single-blind, randomized pilot study conducted at Inha University Hospital, 85 patients undergoing ERCP were equally divided into dome and tapered tip sphincterotome groups. The co-primary outcomes were the success rate of selective biliary cannulation and incidence of post-ERCP pancreatitis. The secondary outcomes included biliary cannulation time, number of unintended pancreatic duct access events, and total procedure time.

Results: The success rates of selective biliary cannulation were 74.4% and 85.7% in the dome and tapered tip groups, respectively, with no significant difference (P = 0.20). Similarly, the incidence of post-ERCP pancreatitis did not differ significantly between the groups (5 cases in the tapered tip group vs 6 in the dome tip group, P = 0.72). However, difficult cannulation was significantly more common in the dome tip group than in the tapered tip group (P = 0.05). Selective biliary cannulation time emerged as a significant predictor of post-ERCP pancreatitis (multivariate odds ratio = 9.33, 95% confidence interval: 1.31-66.44, P = 0.03).

Conclusion: This study indicated that the sphincterotome tip type does not markedly affect biliary cannulation success or post-ERCP pancreatitis rates. However, cannulation duration is a key risk factor for post-ERCP pancreatitis. These findings provide preliminary insights that highlight the importance of refining ERCP practices, including sphincterotome selection, while underscoring the need for larger multicenter studies to improve procedure time and patient safety.