Reversible Portal Vein Embolization Before Major Hepatectomy

NCT ID: NCT02945059

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2022-04-26

Brief 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.

Detailed 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.

Conditions

Liver Regeneration; Reversible Portal Vein Embolization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients will undergo reversible PVE before major hepatic resection.

Group Type: EXPERIMENTAL

Selective reversible portal vein embolization

Intervention Type: PROCEDURE

Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.

Interventions

Selective reversible portal vein embolization

Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antoine Béclère

Clamart, , France

Countries

France

Other Identifiers

P150953

Identifier Type: -

Identifier Source: org_study_id