To estimate the difference in SBDC according to the method and catheter used in a multicenter and multiendoscopist study.
A prospective, multicenter RCT with a 2 ¡Á 2 factorial design.
Fifteen referral endoscopy units.
In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized.
Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]).
Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications.
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).
Non-double-blind study.
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.)