Biliary stenting alone versus biliary stenting plus sphincterotomy for the treatment of post-laparoscopic cholecystectomy biliary leaks: a prospective randomized study.

Objective: Although various endoscopic techniques have been proved effective in treating post-cholecystectomy biliary leaks, the choice of the best method remains controversial. The aim of this prospective study was to compare the efficacy and safety of biliary stenting alone with biliary stenting plus sphincterotomy for the treatment of post-cholecystectomy biliary leaks.

Methods: Patients with post-laparoscopic cholecystectomy leaks were randomized into two groups. The first group included 24 patients who were treated with a 7 Fr biliary stent alone, and the second group included 28 patients who underwent an endoscopic sphincterotomy followed by insertion of a 10 Fr biliary stent.

Results: Endoscopic therapy was successful in all patients (100%). Clinical improvement was observed after 2-6 days. Patients remained hospitalized for 4-12 days. Stents were removed after 6.7 (6-8) weeks. The overall complication rate was 4.16% for the first group and 10.71% for the second (P=0.615). No complications were recorded during the follow-up period.

Conclusions: Endoscopic therapy of biliary leaks with a small-diameter biliary stent alone is as effective and safe as endoscopic sphincterotomy followed by insertion of a large-diameter stent.