Needle-Knife Fistulotomy versus Standard Method for Cannulation of Common Bile Duct: A Randomized Controlled Trial

Background: Endoscopic retrograde cholangiopancreatography with endoscopic sphincterotomy has become widely available for the treatment of pancreatobiliary diseases; however, it has mortality and complications. The aim of this study was to compare the success rates and complications of two different methods of common bile duct cannulation. Methods: From June 2003 though February 2004, patients who were candidates for endoscopic retrograde cholangiopancreatography and/or endoscopic sphincterotomy were randomly divided into two groups: standard cannulation (group A) and suprapapillary needle-knife fistulotomy (group B). Postendoscopic retrograde cholangiopancreatography pancreatitis, cholangitis, bleeding, and perforation were evaluated. Results: Two hundred and eighteen cases (86 males and 132 females with a mean±SD age of 56.2±17.5 years) were enrolled in this study. Group A, contained 112 patients and group B included 106 patients. In group A, the final cannulation success was achieved in 100 patients (89.3%). Cannulation was successful in 88 patients (83.0%) in group B. Difficulty in cannulation occurred more frequently in group A (25.5% vs. 2.6%, P=0.002). There were two patients in group B and three patients in group A who developed pancreatitis after endoscopic retrograde cholangiopancreatography. Perforation occurred in one patient in group B, which was improved with medical support. Bleeding and cholangitis were not occurred in any of the groups. The overall complication rate was 3/112 in group A and 3/106 in group B. Conclusion: Needle-knife fistulotomy is safe and can be applied as an effective alternative to standard technique for common bile duct cannulation in expert hands.