Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
- Obtention of a written informed consent.
- Patient over 18.
- Patient with a type III or IV (according to Bismuth classification) histologically
proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing,
bile cytology, endobiliary biopsy under scope control with pediatric pliers, or by
cytologic puncture under scan or echoendscopic control.
- Patient with Karnofsky score ≥ 50 %
- Patient with an efficient initial biliary drainage with prothesis.
- Cancer classified maximum T3N1M1, but only with intrahepatic metastasis occupying
less than 25% of hepatic parenchyme (according to TNM cancer classification of
extrahepatic biliary ducts' cancers).
- Patient capable of fill in the quality of life questionnaire.
- No written informed consent.
- Type I and II cholangiocarcinoma according to Bismuth classification.
- Patients with ASA score 4.
- Patients with clinical and biological signs of biliary infection.
- Patients with a severe visceral disease other than cholangiocarcinoma.
- Patients without an efficient initial biliary drainage.
- Patients with extrahepatic visceral metastasis, except perihilar ganglionic
metastasis classified T4N1M+ according to TNM classification.
- Patients whose cholangiocarcinoma has already been resected.
- Patients under or already treated by radiotherapy or chemotherapy treatment for
- Patients first treated with metallic prothesis.
- Patients with a contraindication to MRI.
- Patients with porphyria or hypersensibility to porphyrins.
- Patient treated by a non authorized treatment at the time of inclusion.
- Pregnant, parturient or breastfeeding women.
- Non menopaused woman without an efficient contraception.
- Patient under 18.
- Person over 18 under protection according to French Public Health Code.
- Person not affiliated to a social security regimen, or benefiting from such a
- Person in a exclusion period of another biomedical study.