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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02728167
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at the day of consenting to the study.
* Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.
* ECOG PS ≤ 1.
* Adequate bone marrow and liver function at baseline as defined below:
* Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),
* Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.
* Recovered from prior anti-neoplasic treatment-related toxicity (grade \<2 persistent treatment-related toxicity as per CTCAE v4 are accepted).
* Willingness for follow-up visits.
* Covered by a medical insurance.
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
Exclusion Criteria:
* Patients having previously undergone
* a major hepatic surgery (i.e. more than 3 liver segments) or
* biliary major surgery.
* Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.
* Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02728167
Study Brief:
Protocol Section:
NCT02728167