Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT05035433
Eligibility Criteria:
Inclusion Criteria:
1. \>18 years of age
2. For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated \>5 or\<5)
3. During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP
4. Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
5. Subjects voluntarily participate in this study and sign the informed consent
Exclusion Criteria:
1. Coagulation disorders (INR\>1.3) and peripheral blood plate count significantly decreased\<50x10\^9/L
2. Preoperative complicated with acute pancreatitis
3. Preoperative biliary hemorrhage
4. Complicated with severe liver disease and primary sclerosing cholangitis
5. Mirizzi syndrome and intrahepatic bile duct stones
6. Complicated malignant tumor of hepatobiliary and pancreatic system
7. Complicated with obvious stricture of the lower segment of the bile duct
8. intraoperative bile duct duodenal fistula was found
9. Previous EST or EPBD
10. Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05035433
Study Brief:
Protocol Section:
NCT05035433