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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02787512
Eligibility Criteria:
Inclusion Criteria:
A. Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
* Cholangitis defined as revised Tokyo guidelines
* Level of total bilirubin \>= 10mg/dL
* Expected time to operation \>= 7 days
Exclusion Criteria:
A. Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
C. Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
* Patients who take clopidogrel within 5 days before PBD
* Patients who take warfarin within 2 days before PBD
* Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02787512
Study Brief:
Protocol Section:
NCT02787512