ABSTRACT
BACKGROUND AND AIMS: The aim of this study was to assess the safety and efficacy of using needle-knife fistulotomy (NKF) as a primary cannulation technique in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with a native papilla. PATIENTS AND METHODS: This prospective feasibility study enrolled 50 patients between December 2018 and June 2019. The procedure was performed by two expert endoscopists (R.B. and L.H.). The primary outcome was the incidence of post-ERCP pancreatitis. Other variables assessed included the success rate of cannulation of the common bile duct (CBD), time to successful cannulation, and incidence of adverse events. RESULTS: Between December 2018 and June 2019, 50 patients enrolled in the study. The mean age was 63.4 years (standard deviation 18.1), and there were 26 females. Indications included biliary obstruction secondary to malignancy (n = 14) and choledocholithiasis (n = 36). Successful cannulation of the CBD through the fistulotomy occurred in 49/50 cases. The time to successful cannulation was 5.1 minutes (range 0.5 to 23 minutes). Mild acute pancreatitis occurred in two cases (4%). Post-ERCP bleeding occurred in three patients (6%). CONCLUSIONS: In this pilot study, NKF was used as the primary biliary access technique and it was demonstrated that it appears to be at least as safe as the traditional access technique with a sphinctertome. However, its role as a primary cannulation technique requires further investigation with multicenter, randomized control studies.
