Reversible Portal Vein Embolization Before Major Hepatectomy (NCT02945059) | Clinical Trial Compass
CompletedNot Applicable
Reversible Portal Vein Embolization Before Major Hepatectomy
France33 participantsStarted 2018-01-15
Plain-language summary
The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE
Timeframe: 4-6 weeks after portal vein embolization