Abstract
BACKGROUND: The guidewire biliary cannulation (GWC) technique may increase the cannulation rate and decrease the risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. The aim of our multicenter prospective randomized controlled trial was to determine if the use of an atraumatic loop-tip guidewire reduces the rate of post-ERCP pancreatitis (PEP) compared with the standard contrast-assisted cannulation (CC) technique. METHODS: From June 2012 to December 2013, a total of 320 patients who had a naïve papilla and were referred for ERCP were randomly assigned to the GWC group (n = 160) or the CC group (n = 160). GWC or CC was randomly used. In cases of failed cannulation in both arms after crossover, biliary access was attempted with alternative techniques (e. g., dual-wire technique, pancreatic duct stenting, precut). RESULTS: The biliary cannulation rates were 81 % in the GWC group and 73 % in the CC group (P = n. s.). Following crossover, cannulation was successful in 8 % and 11 % of patients in the GWC and CC groups, respectively. With use of an alternative technique, the cannulation rates were 98 % in the GWC group and 96 % in the CC group, respectively. The rates of PEP were 5 % in the GWC group and 12 % in the CC group (P = 0.027). The post-interventional complication rates did not differ between the two groups. CONCLUSION: GWC with the new wire guide is associated with a lower rate of PEP in comparison with the CC technique. Clinical trial reference number: NCT01771419.