Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 21, 2015; 21(23): 7289-7296
Published online Jun 21, 2015. doi: 10.3748/wjg.v21.i23.7289
Is endoscopic papillary large balloon dilatation without endoscopic sphincterotomy effective?
Shigefumi Omuta, Iruru Maetani, Michihiro Saito, Hiroaki Shigoka, Katsushige Gon, Junya Tokuhisa, Mieko Naruki
Shigefumi Omuta, Iruru Maetani, Michihiro Saito, Hiroaki Shigoka, Katsushige Gon, Junya Tokuhisa, Mieko Naruki, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo 153-8515, Japan
Author contributions: Omuta S analyzed and interpreted the data; drafted the article, collected the data and conceived and designed the study; Maetani I conceived and designed the study, critically revised the article and collected the data; Saito M treated the patients and collected the data; Shigoka H also collected the data; Gon K, Tokuhisa J and Naruki M contributed to the treatment of the patients and collected the data; all authors approved the final version of the paper.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Iruru Maetani, MD, PhD, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6, Ohashi Meguro-ku, Tokyo 153-8515, Japan. mtnir50637@med.toho-u.ac.jp
Telephone: +81-3-34681251 Fax: +81-3-54650210
Received: September 17, 2014
Peer-review started: September 18, 2014
First decision: October 29, 2014
Revised: January 5, 2014
Accepted: February 5, 2015
Article in press: February 5, 2015
Published online: June 21, 2015
Processing time: 275 Days and 18.6 Hours
Abstract

AIM: To evaluate the safety and efficacy of endoscopic papillary large balloon dilatation (EPLBD) without endoscopic sphincterotomy in a prospective study.

METHODS: From July 2011 to August 2013, we performed EPLBD on 41 patients with naïve papillae prospectively. For sphincteroplasty of EPLBD, endoscopic sphincterotomy (EST) was not performed, and balloon diameter selection was based on the distal common bile duct diameter. The balloon was inflated to the desired pressure. If the balloon waist did not disappear, and the desired pressure was satisfied, we judged the dilatation as complete. We used a retrieval balloon catheter or mechanical lithotripter (ML) to remove stones and assessed the rates of complete stone removal, number of sessions, use of ML and adverse events. Furthermore, we compared the presence or absence of balloon waist disappearance with clinical characteristics and endoscopic outcome.

RESULTS: The mean diameters of the distal and maximum common bile duct were 13.5 ± 2.4 mm and 16.4 ± 3.1 mm, respectively. The mean maximum transverse-diameter of the stones was 13.4 ± 3.4 mm, and the mean number of stones was 3.0 ± 2.4. Complete stone removal was achieved in 97.5% (40/41) of cases, and ML was used in 12.2% (5/41) of cases. The mean number of sessions required was 1.2 ± 0.62. Pancreatitis developed in two patients and perforation in one. The rate of balloon waist disappearance was 73.1% (30/41). No significant differences were noted in procedure time, rate of complete stone removal (100% vs 100%), number of sessions (1.1 vs 1.3, P = 0.22), application of ML (13% vs 9%, P = 0.71), or occurrence of pancreatitis (3.3% vs 9.1%, P = 0.45) between cases with and without balloon waist disappearance.

CONCLUSION: EST before sphincteroplasty may be unnecessary in EPLBD. Further investigations are needed to verify the relationship between the presence or absence of balloon waist disappearance.

Keywords: Endoscopic papillary large balloon dilatation; Difficult bile duct stone; Endoscopic sphincterotomy; Distal common bile duct; Perforation

Core tip: Optimal approaches to sphincteroplasty of endoscopic papillary large balloon dilatation (EPLBD) remain controversial. We evaluated sphincteroplasty in EPLBD. Forty-one patients with naïve papillae received EPLBD. During sphincteroplasty of EPLBD, endoscopic sphincterotomy (EST) was not performed. Complete stone removal, number of sessions, use of mechanical lithotripter (ML), and adverse events were assessed. Complete stone removal was achieved in 97.5% of cases, and ML was used in 12.2% of cases. The mean number of sessions required was 1.2 ± 0.62. Pancreatitis developed in two patients and perforation in one. EST before sphincteroplasty may be unnecessary in EPLBD.