ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly (COFFEE)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Cholelithiasis; Cholecystectomy, Laparoscopic; Choledocholithiasis

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07001423

8971

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Cholecystectomy

Active Comparator group

Description:

Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.

Treatment:

Procedure: Laparoscopic cholecystectomy

Wait-and-see

No Intervention group

Description:

After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand.