Comparing three treatments for gallbladder stones with common bile duct stones

Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.

This study tests which of three approaches—endoscopic gallbladder-preserving stone removal, ERCP with laparoscopic gallbladder removal, or conservative care—works best for adults with gallbladder stones and stones in the common bile duct.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07413068 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with imaging-confirmed gallbladder and common bile duct stones, gallbladder stones ≤1 cm and normal gallbladder anatomy, and no prior biliary surgery who can consent to their preferred treatment.

Not a fit: Patients with large or complicated stones, atrophic or porcelain gallbladder, suspected gallbladder cancer, biliary strictures, prior biliary reconstruction, or major medical contraindications to endoscopy or surgery are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the study could identify a safer or more effective option that preserves the gallbladder or reduces complications for patients with both gallbladder and common bile duct stones.

How similar studies have performed: ERCP plus laparoscopic cholecystectomy is an established approach with good supporting evidence, whereas transpapillary gallbladder-preserving cholecystolithotomy is less well-studied and remains relatively novel.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• 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

Conditions: Cholelithiasis Associated With Common Bile Duct Stones, Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment