ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.

Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p<0.001 (chi-square test) between the study arms.

Inclusion Criteria:

• Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP)
• Age >= 80 years or age 75-79 years with a Charlson Comorbidity index >=2
• gallbladder in situ

Exclusion Criteria:

• Acute Cholecystitis
• Biliary Pancreatitis
• Severe or moderately severe post-ERCP pancreatitis
• Chronic pancreatitis
• Bile duct pathology
• Widespread malignancy
• Unable to give consent