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N Abraham, S Williams, K Thompson, D MacIntosh, M KhaliqKareemi, J Love

Dalhousie University, Halifax, Nova Scotia

BACKGROUND & AIM: Cannulation difficulty is a known risk factor for post ERCP complications. The most frequently used sphincterotome for CBD cannulation is the 5 French. A smaller caliber 4 French sphincterotome (the “Minitome”) also exists and may provide greater ease of cannulation due to its smaller size and greater flexibility. The aim of this study was to examine the efficacy of common bile duct cannulation using 4 French vs. 5 French sphincterotomes in adult patients undergoing their first ERCP.

METHODS: Adult patients undergoing their first ERCP at the QEII Health Sciences Centre were randomized to undergo cannulation of their common bile duct with either the 4 French or 5 French sphincterotome. Cannulation success, as defined by successful deep cannulation in <15 attempts, was the efficacy outcome of interest. Secondary outcomes included: number of attempts to cannulation, incidence of complications, and time to cannulation. Data was collected during and immediately following each ERCP and patient interviews were completed 24 hours post ERCP to assess for complications. Analysis was intention to treat and included standard descriptive and inferential methods.

RESULTS: 107 patients were randomized: 51 (4 French) vs. 56 (5 French). The majority of patients were female (71%) and Caucasian (92%). The most common indication was suspected choledocholithiasis (71%). Baseline demographics, presenting symptoms, and laboratory values were similar in both arms. Similar cannulation success rates were observed: 84.31% (4 French) and 83.93% (5 French). No differences were noted in: time to cannulation (307.32 sec [SD 287.99] for 4 Fr vs. 267.38 sec [SD 247.69] for 5 Fr), the number of attempts to cannulation (6.16 [SD 5.20] for 4 Fr vs. 5.73 [SD 4.94] for 5 Fr), or complications.

CONCLUSIONS: This study demonstrates that there is no significant difference between 4 French and 5 French sphincterotomes in the efficacy of CBD cannulation. The similar time and number of attempts required for cannulation as well as the similar complication rate imply that these two sphincterotomes are comparable. The choice of initial sphincterotome should be mediated by physician preference.

Completion of this study was assisted by an Unrestricted Research Grant from Cook (Canada) Inc.

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