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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT02841800
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for this study:
1. 20 Years and older.
2. The diagnosis of hepatopancreaticobiliary cancers with pathologic proven, and the diagnosis of hepatopancreaticobiliary cancers will be made by pathology / cytology or according to the American Association for the Study of Liver Diseases (AASLD) (2010) diagnostic criteria.
3. Participant unsuitable for surgical resection. Criteria for unresectability being based on metastatic disease or locally advanced.
4. Eastern Cooperative Oncology Group (ECOG) score of 0-1.
5. American Society of Anaesthesiologists (ASA) score ≤ 3.
6. Karnofsky score \>30.
7. Jaundice (bilirubin level over 10 mg/dL). Alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal.
8. Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0. Platelet count ≥ 100 K/Μl.
9. Expected to survive more than 3 months.
Exclusion Criteria:
* Patients presenting with any of the following will not be enrolled into this study:
1. Under the age of 20 years old.
2. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
3. Known history of human immunodeficiency virus (HIV) infection.
4. Patients who have any serious or systemic disease that is not a good fit for this test.
5. Tumor occupying more than 50% of liver parenchyma
6. Any active metal implanted device (eg Pacemaker).
7. Guidewire cannot pass through the bile duct stenosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02841800
Study Brief:
Protocol Section:
NCT02841800