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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00540735
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 cholangiocarcinoma.
* 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 regimen.
* Person in a exclusion period of another biomedical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00540735
Study Brief:
Protocol Section:
NCT00540735