Cholelithiasis Associated With Common Bile Duct Stones
Conditions
Keywords
Cholelithiasis with Concomitant Choledocholithiasis, Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment
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.
Interventions
PROCEDUREendoscopic transpapillary gallbladder-preserving
Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
PROCEDUREERCP plus Laparoscopic Cholecystectomy
Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
DRUGConservative treatment
Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.
Sponsors
Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Shandong Province Third hospital
Qingdao Municipal Hospital
Shengli Oilfield Hospital
Liaocheng People's Hospital
Binzhou Medical University
Weifang People's Hospital
Taian City Central Hospital
Qianfoshan Hospital
Linyi People's Hospital
Qilu Hospital of Shandong University (Qingdao)
Central Hospital of Zibo
The Second Hospital of Shandong University
Dezhou Hospital Qilu Hospital of Shandong University
Rizhao People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTZhen Li, MD
PRINCIPAL_INVESTIGATORTao Yu, MD
Qilu Hospital of Shandong University
Outcome results
None listed