Safety and efficacy of precut needle-knife fistulotomy.

OBJECTIVE. Although precut is considered an useful alternative when standard methods of biliary access have failed, there is some controversy about it's safety. The study aim was to evaluate the effectiveness of needle-knife fistulotomy (NKF) after a difficult biliary cannulation and whether common bile duct (CBD) diameter influenced complications. MATERIAL AND METHODS. Between November 2006 and December 2010, a total of 1087 consecutive patients with naive papilla were submitted to endoscopic retrograde cholangiopancreatography (ERCP) for biliary access, in an affiliated university hospital. If the biliary cannulation was unsuccessful after 12-15 min, a NKF was performed. The main outcomes were biliary cannulation rate, NKF success and post-ERCP complications. RESULTS. Biliary cannulation by standard methods was successful in 883 patients (81%). In the remaining 204 patients, NKF was performed and allowed CBD access in 166 (81%), leading to a 96% cannulation rate. A second ERCP was performed in 25 patients, with an NKF success of 90% and an overall biliary cannulation rate of 98%. The post-ERCP complication rate was 7.9% (n = 16) with a 6.4% pancreatitis rate and no deaths. The complication for patients with a CBD ≤ to 4 mm was 13.9% compared with 4.5% in the remaining patients (OR = 3.39, p = 0.024). CONCLUSIONS. NKF is a safe and highly useful method of accessing the CBD in the setting of a difficult biliary cannulation. Despite its safety profile, extra caution is needed when applying NKF to patients with thin bile ducts.