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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03172832
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis)
2. Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL
3. Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation
Exclusion Criteria:
1. Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture
2. Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture
3. Recent gallbladder/biliary surgery within 12 months
4. Known Mirizzi syndrome
5. Known IgG4-mediated cholangiopathy
6. Significant liver metastatic disease interfering with safe/effective PTBD
7. Significant ascites interfering with safe/effective PTBD
8. Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent EUS-FNA
9. Prior ERCP or PTBD for hilar obstruction
10. Surgically altered luminal anatomy other than prior Billroth reconstruction or Whipple resection
11. Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy, etc.)
12. Inability or unwillingness to follow study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03172832
Study Brief:
Protocol Section:
NCT03172832