Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial

Background: ERCP can be associated with serious complications. Difficulty in con-inion bile duct (CBD) cannulation is one of the main risk factors for post-ERCP pancreatitis. The double-guidewire technique (DGT) has been considered a promising alternative approach in difficult cannulation situations. Objective: To compare the performance of DGT with the standard cannulation technique (SCT) in patients in whom CBD cannulation is difficult to perform. Design: Multicenter randomized, controlled trial. Setting: Six tertiary referral centers. Patients: A total of 188 patients with difficult CBD cannulation defined by completion of 5 unsuccessful cannulation attempts were enrolled. Interventions: Ninety-seven patients were assigned to the DGT group and 91 to the SCT group. Both techniques were compared for an extra 10 cannulation attempts. Main Outcome Measurements: CBD cannulation rate, number of attempts required to cannulate, and ERCP-related complications. Results: Successful CBD cannulation was achieved in 46 of 97 (47%) patients in the DGT group compared with 51 of 91 (56%) in the SCT group (OR 0.85; 95% CI, 0.64-1.12). The median number of attempts required for each group Was 9 and 7, respectively (P = .128). The incidence of post-ERCP pancreatitis was 17% in the DGT group and 8% in the SCT group (OR 2.13; 95% CI, 0.89-5-05). Limitations: Reduced number of enrolled Subjects and a lack of detailed information regarding the number and extent of pancreatic duct Contrast injections. Conclusions: in patients with difficult CBD cannulation, DGT was not superior to SCT in achieving CBD cannulation. DGT might be associated with a higher risk of post-ERCP pancreatitis. (This study has been registered in ClinicalTrials.gov with identifier NCT00270868.) (Gastrointest Endosc 2009;70:700-9.)