cqvip:Background:Cannulation of the common bile duct(CBD)is the first step in endoscopic retrograde cholangiopancreatography(ERCP).Cannulation difficulty is a known risk factor for post-ERCP complications and may be minimized by the use of a smaller caliber sphincterotome.Objective:To compare the efficacy of CBD cannulation with a 4 F versus a 5 F sphincterotome.Design:A randomized controlled trial,with concealed allocation and double-blinding.Patients:Adult patients undergoing their first ERCP at a tertiary referral center.Intervention:Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome.Main Outcome Measurements:Successful deep cannulation in < 15 attempts was the primary outcome.Secondary outcomes included number of attempts/time to cannulation,incidence of complications within 24 hours,and overall cannulation success(including patients before and after crossover).Analysis was intention to treat and included standard descriptive and inferential methods.Results:A total of 107 patients were randomized:51(4 F)versus 56(5 F).The majority were female(71%)and white(92%).Baseline demographics,presenting symptoms,and laboratory values were similar between groups.Similar success in initial cannulation was observed:84.3%(4 F)and 83.9%(5 F).No differences were noted in time to cannulation(5.12 min SD,4.8 for 4 F vs 4.46 min SD,4.13 for 5 F;p = NS),number of attempts to cannulation(6.2 SD,5.2 for 4 F vs 5.7 SD,4.9 for 5 F;p = NS),or complications.The overall cannulation success was 92.2%(4 F)and 92.9%(5 F).Limitations:Premature termination of the trial resulted in decreased power.Conclusions:There exists no significant difference in efficacy between 4 Fand 5 F sphincterotomes.The choice of initial sphincterotome should be dictated by physician preference.
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