Early use of double-guidewire technique to facilitate selective bile duct cannulation: the multicenter randomized controlled EDUCATION trial

Background and study aims: There are no guidelines for the timing of conversion from a single-guidewire to a double-guidewire technique to facilitate selective bile duct cannulation and reduce post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), when using wire-guided cannulation. We investigated whether early conversion to the double-guidewire method, at first unintentional insertion of a guidewire into the pancreatic duct, facilitated selective bile duct cannulation and reduced PEP compared with repeated single-guidewire attempts. Patients and methods: A multicenter prospective randomized controlled trial included 274 patients with a naive papilla, undergoing endoscopic retrograde cholangiography (ERC) using wire-guided cannulation in whom there was unintentional insertion of the guidewire into the pancreatic duct. With the guidewire still in the duct, patients were randomly assigned to undergo the double-guidewire technique or repeated single-wire cannulation. Main outcomes were success rates for selective bile duct cannulation and PEP frequency. Results: Success rates for selective bile duct cannulation within 10 attempts and 10 minutes were 75% and 70%, respectively, for the early double-guidewire (EDG) and repeated single-guidewire (RSG) cannulation groups (relative rate 1.07, 95% confidence interval [95 %CI] 0.93-1.24, P=0.42). Corresponding final selective bile duct cannulation rates were 98% and 97% (relative rate 1.01, 95% CI 0.97-1.05, P=1.00). PEP rates were 20% and 17%, respectively, for the EDG and RSG cannulation groups (relative risk 1.17, 95% CI 0.71-1.94, P=0.53). Double-guidewire cannulation was more effective in patients with malignant biliary stricture (relative rate 1.36, 95% CI 1.05-1.77, P=0.02). Conclusions: During therapeutic ERC using wire-guided cannulation, converting to a double-guidewire technique neither facilitated selective bile duct cannulation nor decreased PEP incidence compared with repeated use of a single-wire technique.