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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT02232932
Eligibility Criteria:
Inclusion Criteria:
* Patients (male or female) aged from 18 to 68 year-old, French
* Hilar cholangiocarcinoma histologically proved and/or highly suspected on hilar stenosis with mass syndrome from 0.1 cm to 3 cm
* Hilar cholangiocarcinoma type 2, type 3A, type 3B, type 4
* Patients considered as resectable (R0 resection) by liver resection including segment 1 and biliary confluence with or without vascular resection
* Patient potentially transplantable
* Patient affiliated to French Health Insurance
* Patient who had sign an informed consent
Exclusion Criteria:
* Pregnant or breastfeeding woman
* Women of childbearing potential without an effective contraception method
* Radiotherapy contraindication
* Positive dosage of ImmunoglobulinsG4 (IgG4)
* dihydro-pyrimidine-dehydrogenase (DPD) total deficit
* Personal history of cancer in the last 5 five years (exclusion basocellular cellular carcinoma)
* Personal history of fluoropyrimidine hypersensibility
* Personal history of capecitabine hypersensibility
* Personal history of dihydro-pyrimidine-dehydrogenase deficit
* Polynuclear neutrophil \< 1500 / ml
* Platelet rate \< 100 000 / ml
* Severe leucopenia \< 2000 / ml
* Severe liver failure (Factor V \< 50%)
* Severe renal failure (Creatin clearance \< 30 ml/min)
* Treatment by Sorivudine or its analogue as Brivudine
* Non controled diabetes mellitus and/or others severe co-morbidities (renal failure, severe and instable coronaropathy, severe risk factor of stroke, body mass index superior to 35)
* Proved histological cirrhosis
* Sclerosing cholangitis
* Intra and/or extra-hepatic metastases
* Hypereosinophilia and/or wirsung dilatation and/or mass of the pancreas head
* Hilar mass superior to 3 cm
* Duodenal invasion
* Patient under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT02232932
Study Brief:
Protocol Section:
NCT02232932