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A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study

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Title: A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study
Authors: Kawakami, Hiroshi Browse this author →KAKEN DB
Maguchi, Hiroyuki Browse this author
Mukai, Tsuyoshi Browse this author
Hayashi, Tsuyoshi Browse this author
Sasaki, Tamito Browse this author
Isayama, Hiroyuki Browse this author
Nakai, Yousuke Browse this author
Yasuda, Ichiro Browse this author
Irisawa, Atsushi Browse this author
Niido, Teitetsu Browse this author
Okabe, Yoshinobu Browse this author
Ryozawa, Shomei Browse this author
Itoi, Takao Browse this author
Hanada, Keiji Browse this author
Kikuyama, Masataka Browse this author
Arisaka, Yoshifumi Browse this author
Kikuchi, Shogo Browse this author
Issue Date: Feb-2012
Publisher: Mosby
Journal Title: Gastrointestinal Endoscopy
Volume: 75
Issue: 2
Start Page: 362
End Page: 372
Publisher DOI: 10.1016/j.gie.2011.10.012
PMID: 22248605
Abstract: Background: Wire-guided cannulation (WGC) with a sphincterotome 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 multi-endoscopist study. Design: A prospective multicenter RCT with a 2-by-2 factorial design. Setting: Fifteen referral endoscopy units. Patients: In total, 400 consecutive patients with naïve papilla who were candidates for ERCP were enrolled and randomized. Interventions: Patients were assigned to 4 groups according to combined catheter (sphincterotome (S) or catheter (C)) and method (with/without guidewire (GW)). Main Outcome Measurements: Success rate of SBDC in 10 min, time for SBDC, fluoroscopic time and incidence of complications. Results: There was no significant difference in SBDC success rate between with- and without-GW, between C and S, or between 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 min or less (P = 0.036 and 0.00004, 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 fluoroscopic 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.
Type: article (author version)
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 河上 洋

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