Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholi… (NCT07413068) | Clinical Trial Compass
RecruitingNot Applicable
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
China300 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
✕
What they're measuring
1
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
Timeframe: From enrollment to 3 years after the end of treatment
. 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);