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Recruiting NCT07413068

Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis

— Observational Cholelithiasis Associated With Common Bile Duct Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic transpapillary gallbladder-preserving, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment.
Who it may be relevant to
Registry conditions: Cholelithiasis Associated With Common Bile Duct Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure endoscopic transpapillary gallbladder-preserving
    Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
  • Procedure ERCP plus Laparoscopic Cholecystectomy
    Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
  • Drug Conservative treatment
    Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.

Primary outcome measures

  • Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications. [Time frame: From enrollment to 3 years after the end of treatment]
Secondary outcome measures (2)
  • Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis. [Time frame: From enrollment to 3 years after the end of treatment]
  • Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment. [Time frame: From enrollment to 3 years after the end of treatment]

Eligibility criteria

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;
  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07413068 · 2025SDU-QILU-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗