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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01016002
Eligibility Criteria:
Inclusion Criteria:
* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
1. Bismuth type III or IV ( not resectable with R0-margins )
2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
* sufficient general condition to undergo PDT (Karnofsky status \> 30%)
* age \> 19 years
* access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
* informed written consent
Exclusion Criteria:
* porphyria or other diseases exacerbated by light
* known intolerance or allergies to porphyrin derivatives
* a planned surgical procedure within the next 30 days
* coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
* impaired kidney or liver function (creatinine \> 2.5x elevated, INR \> 2.2 on vitamin K),
* leukopenia ( WBC \< 2000/cmm ) or thrombopenia ( \< 50000/cmm ),
* cytotoxic chemotherapy within the past 4 weeks.
* pregnancy ( and safe contraception for 6 months after PDT )
* accompanying/complicating disease with very poor prognosis (expected survival \< 6 weeks),
* proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01016002
Study Brief:
Protocol Section:
NCT01016002