Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study

Background: Temporary biliary stenting is both technically easy and feasible, and choleretic agents such as ursodeoxycholic acid (UDCA) and a terpene preparation may promote a reduction in stone size. However, there are few comparative data on the effectiveness of choleretic agents available. Objective: To investigate the efficacy of multiple double-pigtail stents with or without UDCA and terpene on difficult common bile duct (CBD) stones. Design: A prospective, multicenter study. Setting: Four tertiary-care referral centers. Patients: This study involved 51 patients. Intervention: In total, 51 elderly patients with comorbidities who had difficult CBD stones refractory to conventional methods were randomized to receive either multiple 7F double-pigtail stents (group A) or stents in combination with UDCA and terpene (group B) for a period of 6 months. Main Outcome Measurements: Stone size reduction, successful duct clearance, and complications. Results: Complete endoscopic duct clearance was achieved in 14 patients (73.7%) in group A and 19 patients (86.4%) in group B (P = .826). The mean size of CBD stones (transverse/longitudinal diameter, mean +/- SD) was 19.12 +/- 4.48 mm/20.47 +/- 3.86 mm in group A and 21.30 +/- 7.08 mm/22.58 +/- 7.61 mm in group B. Stone size decreased significantly to 12.04 +/- 3.26 mm/13.31 +/- 5.12 mm and 13.67 +/- 5.40 mm/14.04 +/- 6.12 mm, respectively (P < .01). However, there was no statistical difference in stone size reduction between the two groups (P = .685, P = .289). No serious complications related to the stent or endoscopic procedures were observed, except for cholangitis (n = 1, group A) and distal stem migration (n = 2, group B). Limitations: Small number of patients in East Asia. Conclusion: Temporary multiple double-pigtail biliary stenting was a safe and feasible method of treating difficult and large CBD stones in elderly patients and contributed to a reduction in stone size and successful duct clearance. However, the addition of choleretic agents did not result in a statistical difference in stone size or rate of successful duct clearance. (Gastrointest Enclose 201174:96-102.)