ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best approach for elderly patients who have had their common bile duct stones successfully removed using a procedure called endoscopic retrograde cholangiopancreatography (ERCP). The researchers want to find out if performing laparoscopic cholecystectomy (a minimally invasive surgery to remove the gallbladder) is safer and more effective than waiting to see if any problems arise after the stone removal. They will look at serious outcomes, such as death, major complications from surgery, or the return of biliary disease within a year after patients are enrolled in the study.

To be eligible for this trial, participants need to be at least 75 years old and have had their bile duct stones removed. Specifically, those aged 80 and above can participate, while those aged 75 to 79 must have certain health conditions that indicate they are at higher risk. It’s important to note that people with conditions like acute cholecystitis (inflammation of the gallbladder), severe pancreatitis, or certain cancers cannot join the study. If you qualify and choose to participate, you will be randomly assigned to either have the gallbladder removed or to wait and monitor your condition, and your health will be closely monitored for a year.

Gender

ALL

Eligibility criteria

• 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