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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02945059
Eligibility Criteria:
Inclusion Criteria:
Patient aged between 18 and 80 years
* Patient requiring major liver resection (at least 3 segments)
* PVE indication decided in a multidisciplinary meeting
* Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period
* Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures
* Patient affiliated to the French National Social Security System
Exclusion Criteria:
* American Score of Anesthesiologist (ASA) \> 3
* Extensive Portal vein or hepatic vein thrombosis
* Patient not covered by social security service
* Patient under guardianship
* Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
* Patients who have already had anaphylactic or anaphylactoid reactions during the injection of iodinated contrast medium (edema of Quincke…)
* Patients with an allergy to pork products During the hospitalization and before the PVE
* Severe renal insufficiency (glomerular filtration rate ≤ 30mL/min eg calculated based on the Cockcroft formula).
* Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method during the participation to the research (hormonal contraception with implants or oral contraceptives, or intrauterine devices).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02945059
Study Brief:
Protocol Section:
NCT02945059