5F sphincterotomes and 4F sphincterotomes are equivalent for the selective cannulation of the common bile duct.
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.


METHODS
A randomized controlled trial, with concealed allocation and double-blinding.


METHODS
Adult patients undergoing their first ERCP at a tertiary referral center.


METHODS
Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome.


METHODS
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).


CONCLUSIONS
Premature termination of the trial resulted in decreased power.


CONCLUSIONS
There exists no significant difference in efficacy between 4 F and 5 F sphincterotomes. The choice of initial sphincterotome should be dictated by physician preference.
The Houston Center for Quality of Care and Utilization Studies, the Michael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe Boulevard, Houston, TX 77030, USA. nabraham@bcm.tmc.edu
Neena S
NS
Abraham
Stacey P
SP
Williams
Kara
K
Thompson
Jonathon R
JR
Love
Donald G
DG
MacIntosh
D000328:Adult; D002138:Calibration; D002404:Catheterization / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D001651:Cholestasis, Extrahepatic / Q000601:surgery*; D003135:Common Bile Duct / Q000601:surgery*; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic / Q000295:instrumentation*; D016896:Treatment Outcome