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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Helsinki University Hospital, Jorvi
  Espoo, Finland Recruiting
• Helsinki University Hospital, Meilahti
  Helsinki, Finland Recruiting
• Kanta-Häme Central Hospital
  Hämeenlinna, Finland Not yet 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

Study contacts

• Principal investigator: Panu Mentula, MD, PhD — Helsinki University Central Hospital
• Study coordinator: Panu Mentula, MD, PhD
• Email: panu.mentula@hus.fi
• Phone: +358504270183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.