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

• 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), also known as Conservative treatment group: Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.

Primary outcomes

• Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications. [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

• 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]: 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.
• 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]: 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.

Sex: All, ages: 18 Years to any

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;

• Tao Yu, MD, Principal investigator, Qilu Hospital of Shandong University