Reversible Portal Vein Embolization Before Major Hepatectomy (EMBORES)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Reversible Portal Vein Embolization

Liver Regeneration

Treatments

Procedure: Selective reversible portal vein embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT02945059

P150953

Details and patient eligibility

About

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.

Full description

Portal vein embolization (PVE) is used before major hepatectomy to induce hypertrophy of the future liver remnant (FLR). A non-reversible absorbable material is generally used for embolization, as it provides effective, permanent vascular occlusion. Our team has developed a minimally invasive technique of reversible PVE using gelfoam powder. The aim of this study is to assess the tolerance and efficiency of preoperative reversible selective PVE in patients requiring major hepatic resection. We hypothesize that preoperative reversible PVE allows to similarly increase FLR volume in comparison with classical non-reversible PVE in patients requiring major liver resection with limited FLR.

The hypertrophy ratio after classical non-reversible PVE is evaluated in literature as 13%. We estimated the hypertrophy ratio after reversible PVE as 9% in a previous retrospective study.

The aim of this pilot study is to prospectively evaluate the hypertrophy ratio after reversible PVE.

Primary End Point: Hypertrophy ratio of FLR volume / total liver volume between the baseline and after PVE, assessed by computed tomography scan volumetry 4-6 weeks after PVE.

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).