RANDOMIZED STUDY OF ENDOSCOPIC BILIARY ENDOPROSTHESIS VERSUS DUCT CLEARANCE FOR BILEDUCT STONES IN HIGH-RISK PATIENTS

Background The value of an endoprosthesis for long-term management of bileduct stones has not been formally established. The main theoretica l advantage of endoprosthesis insertion (BE) over conventional endosco pic duct clearance (DC) is the prevention of stone impaction, with obs truction and consequent cholangitis or pancreatitis. In a randomised s tudy we compared the results of these two methods in patients with sym ptomatic bileduct stones who were at high risk because of old age (>70 yr) or serious debilitating disease. Methods 43 high-risk patients we re randomised to BE with a 7F double-pigtail endoprosthesis and (0.75 cm sphincterotomy, and 43 to DC with standard 1.25-1.50 cm sphincterot omy and stone extraction by balloon or basket, with or without mechani cal lithotripsy. The principal endpoint was the rate of biliary relate d complications. Findings In the BE group biliary drainage was achieve d in the first session in all but one patient (who required 2 sessions ). In the DC group, 24 patients had duct clearance at the first attemp t and 35 (81%) after a median of 2 sessions (range 2-4); eight of this group had an endoprosthesis inserted to maintain long-term drainage. At 72 h the complication rates were 7% in the BE group and 16% in the DC group (p=018). However, the long-term complication rate for BE was higher: by Kaplan-Meier analysis, at a median of 20 months the proport ions free of biliary complications were 64% BE and 86% DC (p=0.03, log -rank test). Interpretation For immediate endoprosthesis insertion pro ved alternative to duct clearance. Because of the risk of subsequent c holangitis, its use as a definitive treatment should be confined to hi ghly selected cases.