Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. May 27, 2025; 17(5): 104043
Published online May 27, 2025. doi: 10.4240/wjgs.v17.i5.104043
Dome vs tapered tip sphincterotomes in endoscopic retrograde cholangiopancreatography: A pilot study on cannulation success and postprocedural pancreatitis
Jungnam Lee, Jin-Seok Park
Jungnam Lee, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon 22332, South Korea
Jin-Seok Park, Department of Internal Medicine, Shihwa Medical Center, Siheung-si 15034, Gyeonggi-do, South Korea
Author contributions: Lee J collected, analyzed, and interpreted the data, and wrote the manuscript; Park JS conceived and designed the study, provided study materials, contributed resources, critically revised the manuscript, and approved the final version. All authors participated in editing and approving the final draft of the manuscript.
Supported by the Shihwa Medical Center Research Fund.
Institutional review board statement: The study protocol was approved by the Institutional Review Board of Inha University Hospital (INHAUH 2022-10-008). This study was conducted in accordance with the guidelines of the Declaration of Helsinki and Good Clinical Practice.
Clinical trial registration statement: This study was registered with cris.nih.go.kr (registration number: KCT0009507).
Informed consent statement: The written informed consent was obtained from all participants before the commencement of the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The raw data are available from the corresponding author on reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jin-Seok Park, MD, PhD, Professor, Department of Internal Medicine, Shihwa Medical Center, 381-2, Gunjacheon-ro, Siheung-si 15034, Gyeonggi-do, South Korea. pjsinha@naver.com
Received: December 16, 2024
Revised: February 14, 2025
Accepted: March 12, 2025
Published online: May 27, 2025
Processing time: 158 Days and 23.7 Hours
Abstract
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.

Keywords: Endoscopic retrograde cholangiopancreatography; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Selective biliary cannulation; Sphincterotome tip configuration; Pancreatitis

Core Tip: This pilot study compared dome and tapered tip sphincterotomes in endoscopic retrograde cholangiopancreatography (ERCP), with focus on selective biliary cannulation success and post-ERCP pancreatitis. Although cannulation success and pancreatitis rates did not differ significantly between the two tip types, a prolonged cannulation time was a key predictor of post-ERCP pancreatitis. The tapered tip group encountered fewer cannulation difficulties, suggesting a maneuverability advantage. These findings underscore the importance of minimizing cannulation time and support the need for larger multicenter studies to refine ERCP practices and improve patient safety.