A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
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)
