Randomized Controlled Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2015; 21(30): 9182-9188
Published online Aug 14, 2015. doi: 10.3748/wjg.v21.i30.9182
0.025-inch vs 0.035-inch guide wires for wire-guided cannulation during endoscopic retrograde cholangiopancreatography: A randomized study
Katsuya Kitamura, Akira Yamamiya, Yu Ishii, Yoshiki Sato, Tomoyuki Iwata, Tomohiro Nomoto, Akitoshi Ikegami, Hitoshi Yoshida
Katsuya Kitamura, Akira Yamamiya, Yu Ishii, Yoshiki Sato, Tomoyuki Iwata, Tomohiro Nomoto, Akitoshi Ikegami, Hitoshi Yoshida, Division of Gastroenterology, Department of Medicine, Showa University School of Medicine, Tokyo 142-8666, Japan
Author contributions: Kitamura K designed the study, collected and analyzed the data; Kitamura K drafted the manuscript and gave final approval of the version to be published; Kitamura K, Yamamiya A, Ishii Y, Sato Y, Iwata T, Nomoto T, Ikegami A and Yoshida H took part in this study as endoscopic operators or assistants.
Institutional review board statement: The study was reviewed and approved by the Medical Ethics Committee of Showa University Hospital.
Clinical trial registration statement: This study is registered at UMIN Clinical Trial Registry. The registration identification number is UMIN000010082.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
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: Katsuya Kitamura, MD, PhD, Division of Gastroenterology, Department of Medicine, Showa University School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan. k.kitamura@med.showa-u.ac.jp
Telephone: +81-3-37848535 Fax: +81-3-37847553
Received: January 18, 2015
Peer-review started: January 19, 2015
First decision: February 10, 2015
Revised: February 25, 2015
Accepted: April 28, 2015
Article in press: April 30, 2015
Published online: August 14, 2015
Processing time: 210 Days and 21.9 Hours
Abstract

AIM: To compare the clinical outcomes between 0.025-inch and 0.035-inch guide wires (GWs) when used in wire-guided cannulation (WGC).

METHODS: A single center, randomized study was conducted between April 2011 and March 2013. This study was approved by the Medical Ethics Committee at our hospital. Informed, written consent was obtained from each patient prior to study enrollment. Three hundred and twenty-two patients with a naïve papilla of Vater who underwent endoscopic retrograde cholangiopancreatography (ERCP) for the purpose of selective bile duct cannulation with WGC were enrolled in this study. Fifty-three patients were excluded based on the exclusion criteria, and 269 patients were randomly allocated to two groups by a computer and analyzed: the 0.025-inch GW group (n = 109) and the 0.035-inch GW group (n = 160). The primary endpoint was the success rate of selective bile duct cannulation with WGC. Secondary endpoints were the success rates of the pancreatic GW technique and precutting, selective bile duct cannulation time, ERCP procedure time, the rate of pancreatic duct stent placement, the final success rate of selective bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP).

RESULTS: The primary success rates of selective bile duct cannulation with WGC were 80.7% (88/109) and 86.3% (138/160) for the 0.025-inch and the 0.035-inch groups, respectively (P = 0.226). There were no statistically significant differences in the success rates of selective bile duct cannulation using the pancreatic duct GW technique (46.7% vs 52.4% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.884) or in the success rates of selective bile duct cannulation using precutting (66.7% vs 63.6% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.893). The final success rates for selective bile duct cannulation using these procedures were 92.7% (101/109) and 97.5% (156/160) for the 0.025-inch and 0.035-inch groups, respectively (P = 0.113). There were no significant differences in selective bile duct cannulation time (median ± interquartile range: 3.7 ± 13.9 min vs 4.0 ± 11.2 min for the 0.025-inch and 0.035-inch groups, respectively; P = 0.851), ERCP procedure time (median ± interquartile range: 32 ± 29 min vs 30 ± 25 min for the 0.025-inch and 0.035-inch groups, respectively; P = 0.184) or in the rate of pancreatic duct stent placement (14.7% vs 15.6% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.832). The incidence of PEP was 2.8% (3/109) and 2.5% (4/160) for the 0.025-inch and 0.035-inch groups, respectively (P = 0.793).

CONCLUSION: The thickness of the GW for WGC does not appear to affect either the success rate of selective bile duct cannulation or the incidence of PEP.

Keywords: Endoscopic retrograde cholangiopancreatography; Guide wire; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Selective bile duct cannulation; Wire-guided cannulation

Core tip: The thickness of the guide wire for wire-guided cannulation does not appear to affect either the success rate of selective bile duct cannulation or the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis.