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

NCT07413068 | Recruiting

• 1 other identifier: 2025SDU-QILU-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholelithiasis Associated With Common Bile Duct Stones

Keywords

Cholelithiasis with Concomitant Choledocholithiasis; Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy; ERCP plus Laparoscopic Cholecystectomy; Conservative treatment

Outcome Measures

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.

  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 Outcomes (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.

  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.

  From enrollment to 3 years after the end of treatment

Study Arms (3)

Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy

The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy

Procedure: endoscopic transpapillary gallbladder-preserving

ERCP plus Laparoscopic Cholecystectomy

The patients intend to receive ERCP plus laparoscopic cholecystectomy

Procedure: 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

Interventions

endoscopic transpapillary gallbladder-preserving PROCEDURE

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

Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy

ERCP plus Laparoscopic Cholecystectomy PROCEDURE

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

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.

Also known as: Conservative treatment group

Conservative Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with cholelithiasis with concomitant choledocholithiasis

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic; Conservative Treatment

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cholecystectomy; Biliary Tract Surgical Procedures; Laparoscopy; Therapeutics

Study Officials

• Tao Yu, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD

CONTACT

18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 17, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)