Gallbladder removal versus watchful waiting after bile duct stone removal in older adults

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

This trial tests whether immediate laparoscopic gallbladder removal or a wait-and-see approach is better for older patients after their common bile duct stones have been removed by ERCP.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: Helsinki University Central Hospital (Academic / other)
• Locations: 12 sites (Espoo and 11 other locations)
• Trial ID: NCT07001423 on ClinicalTrials.gov

What this trial studies

This randomized trial enrolls elderly patients whose common bile duct stones were successfully cleared by ERCP and randomizes 400 participants 1:1 to either laparoscopic cholecystectomy (done during the same admission or within two weeks) or a wait-and-see policy. The primary outcome is a composite of death, major postoperative complications, or recurrent biliary disease within one year after randomization. One planned interim safety analysis will be performed after 100 patients, with a strict stopping rule if a clear difference emerges (p<0.001). Eligible patients are generally aged ≥80, or 75–79 with higher comorbidity, and must have the gallbladder in place without active cholecystitis or significant pancreatitis.

Who should consider this trial

Good fit: Ideal candidates are older adults (age ≥80, or 75–79 with a Charlson Comorbidity Index ≥2) who have had common bile duct stones cleared by ERCP and still have their gallbladder, and who can give informed consent.

Not a fit: Patients with acute cholecystitis, recent biliary pancreatitis or severe post-ERCP pancreatitis, chronic pancreatitis, bile duct pathology, widespread malignancy, or those unable to consent are not likely to benefit from this comparison.

Why it matters

Potential benefit: If successful, this could spare many older patients from an unnecessary operation while keeping rates of death, major complications, and recurrent biliary problems low.

How similar studies have performed: Previous smaller trials and observational studies have had mixed results, with some suggesting conservative management can be safe in selected elderly patients, but randomized evidence in this specific high-risk elderly group is limited.

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

Where this trial is running

Espoo and 11 other locations

• Helsinki University Hospital, Jorvi — Espoo, Finland (Recruiting)
• Kanta-Häme Central Hospital — Hämeenlinna, Finland (Not_yet_recruiting)
• Helsinki University Hospital, Meilahti — Helsinki, Finland (Recruiting)
• Pohjois-Karjala Central Hospital — Joensuu, Finland (Not_yet_recruiting)
• Keski-Suomi Central Hospital — Jyväskylä, Finland (Not_yet_recruiting)
• Kymenlaakso Central Hospital — Kotka, Finland (Not_yet_recruiting)
• Kuopio University Hospital — Kuopio, Finland (Not_yet_recruiting)
• Päijät-Häme Central Hospital — Lahti, Finland (Not_yet_recruiting)
• Oulu University Hospital — Oulu, Finland (Not_yet_recruiting)
• Tampere University Hospital — Tampere, Finland (Not_yet_recruiting)
• Turku University Hospital — Turku, Finland (Not_yet_recruiting)
• Vaasa Central Hospital — Vaasa, Finland (Not_yet_recruiting)

Study contacts

• Principal investigator: Panu Mentula, MD, PhD — Helsinki University Central Hospital
• Study coordinator: Panu Mentula, MD, PhD

Conditions Cholecystectomy, Laparoscopic; Choledocholithiasis; Cholelithiasis