Comparing three treatments for gallbladder stones with common bile duct stones

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 observational cohort enrolls adults with cholelithiasis and concomitant common bile duct stones and assigns them to endoscopic transpapillary gallbladder-preserving cholecystolithotomy, ERCP plus laparoscopic cholecystectomy, or conservative treatment based on patient preference. Clinical data and patient-reported outcomes are collected at baseline and during follow-up to measure clinical success and complications. The study compares short-term and long-term postoperative complication rates and overall effectiveness across the three approaches. Eligible patients generally have small gallbladder stones (≤1 cm), normal gallbladder morphology, and no prior biliary or cholecystectomy surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Patients over the age of 18 years;
2. Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
3. Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
4. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
6. Voluntary provision of signed informed consent.

Exclusion Criteria

1. Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
2. Unable to undergo endoscopic interventions for various reasons;
3. Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
4. Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
5. Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) \> 1.5 or patients with significant thrombocytopenia (platelet count \< 50 × 10⁹/L);
6. Pregnant women;

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Tao Yu, MD — Qilu Hospital of Shandong University
• Study coordinator: Zhen Li, MD
• Email: qilulizhen@sdu.edu.cn
• Phone: 18560086106

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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.