open access

https://hdl.handle.net/2115/48387

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

英語

2012-02

Mosby

Gastrointestinal Endoscopy

75(2)

362-372

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.

学術雑誌論文

Accepted Manuscript

0016-5107