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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01275768
Eligibility Criteria:
Inclusion Criteria:
1. Patients: Clinical data and investigations suggestive of unresectable malignant bile duct obstruction. All patients will be discussed at the hepato-biliary multidisciplinary meeting which should come to a unanimous decision on tumor unresectability.
2. Age more than 18 years
3. Histologically/ Cytologically confirmed malignancy
4. Informed consent: The patient should voluntarily agree to participation and randomization. Oral and written information about the nature of the trial will be given to all patients considered for inclusion.
Exclusion Criteria:
1. Informed consent not obtained or withdrawn
2. Extremely poor general condition not amenable for conscious sedation used for ERC
3. Candidate suitable for surgical resection
4. Klatskin type 4 tumor
5. Previous biliary intervention such as plastic stent insertion for more than 1 month
6. Any other contra-indication to ERC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01275768
Study Brief:
Protocol Section:
NCT01275768