THE NEED FOR CHOLECYSTECTOMY AFTER ENDOSCOPIC SPHINCTEROTOMY (ES) FOR BILE DUCT STONE IN ELDERLY PATIENTS: A RANDOMIZED STUDY

Abstract

Background: Long-term biliary complications after ES for bile duct stones are infrequent. In the elderly, the role of routine cholecystectomy after ES is unclear. Patients and Methods: Between September 1997 and December 2000, patients (age >60) with bile duct stones and gall stones presenting with obstructive jaundice, cholangitis or pancreatitis were randomized to receive early elective cholecystectomy (LC) or expectant management after clearance of bile duct stones with ERCP + ES. Exclusion criteria included severe co-morbidity, concomitant intrahepatic duct stones, recurrence pyogenic cholangitis, cholecystitis and failure to clear bile duct stones endoscopically. They were then seen at regular intervals. Outcome variables included further biliary complications defined as: cholangitis, pancreatitis, obstructive jaundice, cholecystitis and severe biliary colic. Results: 165 patients, aged 60–89 years were randomized (85 in LC group & 80 in expectant group). Both groups were similar in age (60–87 vs. 60–89), ASA grading and mode of presentation. Median follow-up period was 24 months. 9 patients developed biliary complications in the expectant group (5 cholangitis, 3 cholecystitis and 1 severe biliary colic) while 1 patient in the LC group refused surgery and developed cholangitis. By intention-to-treat analysis, the expectant group shows higher incidence of biliary complications than the LC group: (9/80 vs. 1/85, p = 0.008; Difference in probability of complications = 13%, 95% C.I. = 4.8%, 21.2%) Conclusion: With higher incidence of biliary complications in the expectant group, cholecystectomy should be offered to patients whenever is possible after endoscopic clearance of bile duct stones.