Background and aim: There are scarce data regarding the impact of sphincterotome design on cannulation success. We aimed to compare two different 5.5 Fr standard sphincterotomes to determine initial cannulation success.
Methods: Adult patients with naive papillae were enrolled in a prospective, randomized, crossover study. Two different 5.5 Fr sphincterotomes preloaded with guidewire (GW) were used in two groups with 140 patients included per group. A total of five papillary attempts and two pancreatic channel entries were allowed as maximum targets. In a case of more than two pancreatic entries, a double GW technique was attempted before crossover. If choledochal cannulation was not achieved within ten papillary attempts or more than four pancreatic entries despite crossover, access papillotomy was performed. Successful biliary cannulation was the primary outcome. Secondary outcomes were incidence of early complications and overall cannulation success.
Results: Higher initial cannulation success was achieved in group I compared with group II (88.5 vs. 77.1%, p = 0.011). The crossover and double GW techniques reduced the need for precut from 11.7 to 5.3%. The overall cannulation success including precut for failed cases was 99.2% (group I) and 98.5% (group II). Sphincterotome type, presence of crossover, and number of cannulation attempts were predictors of successful cannulation in multivariate analysis.
Conclusions: There was a significant difference in cannulation success between two different 5.5 Fr sphincterotomes. The cannulation success was mainly governed by sphincterotome design which serves a proper spatial orientation during the procedure. The combined use of crossover and double GW techniques may substantially decrease precut necessity.