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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01590394
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
1. ≥ 18 and ≤ 85 years of age
2. Malignant biliary obstruction, known or suspected
3. Increased bilirubin or jaundice or history thereof
4. Duct stricture (obstruction) ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)
5. Not an operative candidate
Exclusion Criteria:
1. Unable to obtain consent
2. Unable to tolerate endoscopic procedure
3. Suspected non-malignant bile duct stricture
4. Candidate for potentially curative surgical intervention
5. Previous SEMS
6. Previous bile duct surgery
7. Diffuse liver metastasis
8. Peritoneal metastasis by CT
9. Presence of ascites
10. Duodenal obstruction preventing passage of the duodenoscope to the level of the papilla
11. Failure to cannulate bile duct during ERCP
12. Karnofsky performance score \< 40
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01590394
Study Brief:
Protocol Section:
NCT01590394