NCT07001423

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cholecystectomy, Laparoscopic
• Choledocholithiasis
• Cholelithiasis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy	Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone

Timeline

• Start date: 2025-10-03
• Primary completion: 2031-08-31
• Completion: 2032-08-31
• First posted: 2025-06-03
• Last updated: 2025-10-07

Locations

12 sites across 1 country: Finland