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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT01549795
Eligibility Criteria:
Inclusion Criteria:
* Older than 18 years
* Male or female
* Diagnosis of Cholangiocarcinoma using:
* PTBD biopsy or Brushing cytology
* Ca 19-9\>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
* Non resectable tumour araising above the cystic duct
* Absence of intra and extra hepatic metastasis
* ECOG score(Eastern Cooperative Oncology Group) 0
* ASA score (American Society of Anesthesiologists) ≤ 3
* Ability to understand and willingness to sign the written informed consent form (ICF)
Exclusion Criteria:
* Intrahepatic Cholangiocarcinoma
* Non controlled infection
* Previous radio or chemotherapy
* Previsous bile duct resection or attempt to resection
* Intra and/or extrahepatic metastasis
* Preivious malignant neoplasm (within 5 years)
* Execution of trans peritoneal biopsy
* Tumour diameter more than 3 cm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01549795
Study Brief:
Protocol Section:
NCT01549795