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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cholelithiasis Associated With Common Bile Duct Stones
• Intervention / Treatment: Procedure: endoscopic transpapillary gallbladder-preserving; Procedure: ERCP plus Laparoscopic Cholecystectomy; Drug: Conservative treatment

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250063
      • Recruiting
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with cholelithiasis with concomitant choledocholithiasis

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy; The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy	Procedure: endoscopic transpapillary gallbladder-preserving; Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
ERCP plus Laparoscopic Cholecystectomy; The patients intend to receive ERCP plus laparoscopic cholecystectomy	Procedure: ERCP plus Laparoscopic Cholecystectomy; Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
Conservative Treatment; After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis.	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.; Other Names: Conservative treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.	Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.	From enrollment to 3 years after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.	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.	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.	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.	From enrollment to 3 years after the end of treatment

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The Affiliated Hospital of Qingdao University; Qingdao Municipal Hospital; Qianfoshan Hospital; The Second Hospital of Shandong University; Liaocheng People's Hospital; Linyi People's Hospital; Taian City Central Hospital; Weifang People's Hospital; Shengli Oilfield Hospital; Qilu Hospital of Shandong University (Qingdao); Binzhou Medical University; Rizhao People's Hospital; Shandong Province Third hospital; Central Hospital of Zibo; Dezhou Hospital Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Tao Yu, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Conservative treatment; Cholelithiasis with Concomitant Choledocholithiasis; Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy; ERCP plus Laparoscopic Cholecystectomy
• Additional Relevant MeSH Terms: Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Diagnostic Imaging; Radiography; Biliary Tract Surgical Procedures; Laparoscopy; Cholecystectomy; Cholangiography; Radiography, Abdominal; Conservative Treatment; Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde
• Other Study ID Numbers: 2025SDU-QILU-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No