AIM: To evaluate the effect of wire-guided biliary cannulation (WGC) on the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: We investigated the impact of the WGC technique on the incidence of PEP by comparing the conventional cannulation (CC) technique in selective bile duct cannulation during ERCP with a cross-over design in a prospective multicenter randomized controlled trial and the potential risk factors for PEP. This involved six tertiary referral centers and three university hospitals. A total of 322 patients with indications for ERCP requiring selective biliary cannulation were enrolled from April 2008 to March 2009. RESULTS:One hundred and sixty-three patients were assigned to the WGC group and 159 to the CC group. The incidence of PEP was the same between the groups (6.1% vs 6.3%, P = 0.95). Primary successful biliary cannulation was achieved in 136 patients (83%) in the WGC group and in 138 (87%) in the CC group (P = 0.40). The mean time required for primary successful biliary cannulation was 7.4 ± 8.3 min and 7.2 ± 7.9 min, respectively (P = 0.83). Multivariate analysis demonstrated that accidental guidewire insertions and unintended injections of contrast into the main pancreatic duct were the only independent risk factors for PEP (P = 0.001, relative risk [RR]: 8.70, 95% confidence interval [CI]: 2.46-30.81). CONCLUSION: The WGC technique does not reduce the risk of PEP and also does not improve the success rate of selective bile duct cannulation.
RCT Entities:
AIM: To evaluate the effect of wire-guided biliary cannulation (WGC) on the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: We investigated the impact of the WGC technique on the incidence of PEP by comparing the conventional cannulation (CC) technique in selective bile duct cannulation during ERCP with a cross-over design in a prospective multicenter randomized controlled trial and the potential risk factors for PEP. This involved six tertiary referral centers and three university hospitals. A total of 322 patients with indications for ERCP requiring selective biliary cannulation were enrolled from April 2008 to March 2009. RESULTS: One hundred and sixty-three patients were assigned to the WGC group and 159 to the CC group. The incidence of PEP was the same between the groups (6.1% vs 6.3%, P = 0.95). Primary successful biliary cannulation was achieved in 136 patients (83%) in the WGC group and in 138 (87%) in the CC group (P = 0.40). The mean time required for primary successful biliary cannulation was 7.4 ± 8.3 min and 7.2 ± 7.9 min, respectively (P = 0.83). Multivariate analysis demonstrated that accidental guidewire insertions and unintended injections of contrast into the main pancreatic duct were the only independent risk factors for PEP (P = 0.001, relative risk [RR]: 8.70, 95% confidence interval [CI]: 2.46-30.81). CONCLUSION: The WGC technique does not reduce the risk of PEP and also does not improve the success rate of selective bile duct cannulation.