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NCT Number: NCT07413068

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

endoscopic transpapillary gallbladder-preserving

Procedure

Based on the patient's preference, they will receive the following treatment:endoscopic transpapillary gallbladder-preserving

ERCP plus Laparoscopic Cholecystectomy

Procedure

Based on the patient's preference, they will receive the following treatment:ERCP plus Laparoscopic Cholecystectomy

Conservative treatment

Drug

Based on the patient's preference, they will receive the following treatment:ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.

Other names: Conservative treatment group

Primary outcomes

  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.

    Time frame: From enrollment to 3 years after the end of treatment

    Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.

Secondary outcomes

  1. 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

    Compare the gallbladder stone clearance rate and bile duct stone clearance rate among the three groups; meanwhile, record the rates of successful gallbladder access establishment via FCMS and successful guidewire cannulation into the gallbladder in the gallbladder-preserving cholecystolithotomy group, so as to clarify the clinical success rate and technical success rate of this technique.

  2. 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

    Record duration of Hospitalization and total Medical Expenses of the three groups then calculate them as total medical expenses / duration of hospitalization (Unit: [e.g., CNY/USD] per day).It can reflect the average daily inpatient economic cost for each treatment, enabling integrated comparison of economic efficiency across the three groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li, MD

CONTACT

[email protected]

18560086106

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Binzhou Medical University
  • Central Hospital of Zibo
  • Dezhou Hospital Qilu Hospital of Shandong University
  • Liaocheng People's Hospital
  • Linyi People's Hospital
  • Qianfoshan Hospital
  • Qilu Hospital of Shandong University (Qingdao)
  • Qingdao Municipal Hospital
  • Rizhao People's Hospital
  • Shandong Province Third hospital
  • Shengli Oilfield Hospital
  • Taian City Central Hospital
  • The Affiliated Hospital of Qingdao University
  • The Second Hospital of Shandong University
  • Weifang People's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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