A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study
Hiroshi Kawakami, Hiroyuki Maguchi, Tsuyoshi Mukai, Tsuyoshi Hayashi, Tamito Sasaki, Hiroyuki Isayama, Yousuke Nakai, Ichiro Yasuda, Atsushi Irisawa, Teitetsu Niido, Yoshinobu Okabe, Shomei Ryozawa, Takao Itoi, Keiji Hanada, Masataka Kikuyama, Yoshifumi Arisaka, Shogo Kikuchi, Japan Bile Duct Cannulation Study Group, H Kawakami, M Kuwatani, M Onodera, S Haba, H Maguchi, K Takahashi, A Katanuma, M Osanai, A Kurita, T Kin, K Yane, M Kaneko, S Hashigo, T Mukai, K Iwata, T Hayashi, Y Ishiwatari, T Sasaki, Y Fujimoto, M Serikawa, M Inoue, Y Ishi, T Ishigaki, A Okazaki, M Yukutake, Y Nakai, H Isayama, K Hirano, N Sasahira, H Kogure, T Sasaki, K Kawakubo, H Yagioka, S Mizuno, I Yasuda, M Nakashima, T Yamauchi, S Doi, A Irisawa, T Ikeda, T Takagi, G Shibukawa, R Suzuki, T Niido, Y Okabe, Y Ishida, R Kaji, S Ryozawa, K Taba, H Iwano, T Itoi, F Itokawa, T Kurihara, K Ishii, S Tsuji, K Hanada, N Hirano, T Iiboshi, S Sagami, M Kikuyama, K Matsumura, T Ueda, M Shigetomo, Y Arisaka, Hiroshi Kawakami, Hiroyuki Maguchi, Tsuyoshi Mukai, Tsuyoshi Hayashi, Tamito Sasaki, Hiroyuki Isayama, Yousuke Nakai, Ichiro Yasuda, Atsushi Irisawa, Teitetsu Niido, Yoshinobu Okabe, Shomei Ryozawa, Takao Itoi, Keiji Hanada, Masataka Kikuyama, Yoshifumi Arisaka, Shogo Kikuchi, Japan Bile Duct Cannulation Study Group, H Kawakami, M Kuwatani, M Onodera, S Haba, H Maguchi, K Takahashi, A Katanuma, M Osanai, A Kurita, T Kin, K Yane, M Kaneko, S Hashigo, T Mukai, K Iwata, T Hayashi, Y Ishiwatari, T Sasaki, Y Fujimoto, M Serikawa, M Inoue, Y Ishi, T Ishigaki, A Okazaki, M Yukutake, Y Nakai, H Isayama, K Hirano, N Sasahira, H Kogure, T Sasaki, K Kawakubo, H Yagioka, S Mizuno, I Yasuda, M Nakashima, T Yamauchi, S Doi, A Irisawa, T Ikeda, T Takagi, G Shibukawa, R Suzuki, T Niido, Y Okabe, Y Ishida, R Kaji, S Ryozawa, K Taba, H Iwano, T Itoi, F Itokawa, T Kurihara, K Ishii, S Tsuji, K Hanada, N Hirano, T Iiboshi, S Sagami, M Kikuyama, K Matsumura, T Ueda, M Shigetomo, Y Arisaka
Abstract
Background: Wire-guided cannulation (WGC) with a sphincterotome (S) for selective bile duct cannulation (SBDC) has been reported to have a higher success rate and lower incidence of post-ERCP pancreatitis (PEP) than conventional methods in some randomized, controlled trials (RCTs) that were both single center and limited to only a few endoscopists.
Objective: To estimate the difference in SBDC according to the method and catheter used in a multicenter and multiendoscopist study.
Design: A prospective, multicenter RCT with a 2 × 2 factorial design.
Setting: Fifteen referral endoscopy units.
Patients: In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized.
Interventions: Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]).
Main outcome measurements: Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications.
Results: There was no significant difference in the SBDC success rate between the groups with and without GW, between C and S, or among the 4 groups (C+GW, C, S+GW, S). WGC had a tendency to significantly shorten cannulation and fluoroscopy times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 minutes or less (P = .036 and .00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively).
Limitations: Non-double-blind study.
Conclusions: WGC appears to significantly shorten cannulation and fluoroscopy times. However, neither the method nor type of catheter used resulted in significant differences in either SBDC success rate or incidence of PEP in this RCT. (
Clinical trial registration number: UMIN000002572.).
Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
Source: PubMed