Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.
Qilu Hospital of Shandong University
300 participants
Dec 1, 2025
OBSERVATIONAL
Conditions
Summary
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.
Eligibility
Inclusion Criteria6
- Patients over the age of 18 years;
- Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
- Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
- Voluntary provision of signed informed consent.
Exclusion Criteria6
- Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
- Unable to undergo endoscopic interventions for various reasons;
- Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
- Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
- Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) > 1.5 or patients with significant thrombocytopenia (platelet count < 50 × 10⁹/L);
- Pregnant women;
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Interventions
Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07413068