RANDOMIZED TRIAL OF ENDOSCOPIC SPHINCTEROTOMY WITH GALLBLADDER LEFT IN-SITU VERSUS OPEN SURGERY FOR COMMON BILEDUCT CALCULI IN HIGH-RISK PATIENTS

Background Morbidity and mortality after surgical treatment of bileduc t stones increase with age and associated diseases. A proposed alterna tive therapy is endoscopic sphincterotomy (ES) with the gallbladder le ft in situ, and we selected to compare this option with standard open surgery in high-risk patients. Methods 98 patients (mean age 80 years) with symptoms likely to be due to bileduct stones or a recent episode of biliary pancreatitis were randomised to be treated either by open cholecystectomy with operative cholangiography and (if necessary) bile duct exploration (n=48) or by endoscopic sphincterotomy alone (n=50). Findings The procedure was accomplished successfully in 94% of the sur gery group and 88% of the ES group, and there were no significant diff erences in immediate morbidity (23% vs 16%) or mortality (4% vs 6%). D uring mean follow-up of 17 months biliary symptoms recurred in three s urgical patients, none of whom underwent repeat surgery, and in 10 ES patients, seven of whom had biliary surgery. By multivariate regressio n analysis endoscopic sphincterotomy was an independent predictor of r ecurrent biliary symptoms (odds ratio 6.9; 95% Cl 1.46 to 32.54). Inte rpretation In elderly or high-risk patients, surgery is preferable to endoscopic sphincterotomy with the gallbladder left in situ as a defin itive treatment for bileduct stones or non-severe biliary pancreatitis .