Reversible Portal Vein Embolization Before Major Hepatectomy

NCT02945059 | Completed

• 1 other identifier: P150953
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Regeneration; Reversible Portal Vein Embolization

Keywords

Liver regeneration; portal vein embolization; gelatin powder; liver surgery; hepatectomy

Outcome Measures

Primary Outcomes (1)

• Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE

  Ratio is evaluated by computed tomography scan volumetry 4-6 weeks after portal vein embolization.Volumes will be assessed by one independent blind observer, from anonymized CT scan series. Total, non-embolized (FLR) volume and embolized liver volume (ELV) will be measured. The following formulas will be used to calculate percentage of FLR volume: * FLR volume prePVE = (FLR prePVE volume / (total liver prePVE volume - tumor volume prePVE)) x 100 * FLR volume postPVE = (FLR postPVE volume / (total liver postPVE volume - tumor volume postPVE)) x 100 The following formulas will be used to calculate hypertrophy ratio: %FLR volume postPVE - %FLR volume prePVE

  4-6 weeks after portal vein embolization

Secondary Outcomes (10)

• Technical feasibility: Percentage of completed PVE

  During the procedure of portal vein embolization

• Technical feasibility: Percentage of partially completed PVE

  During the procedure of portal vein embolization

• Technical feasibility: Percentage of not performed PVE

  During the procedure of portal vein embolization

• Per and post procedure (within 6 weeks) morbidity

  During PVE and within 6 weeks after embolization

• Liver tolerance

  At Day0, Day1 and Day7 after portal vein embolization

Study Arms (1)

1

EXPERIMENTAL

Patients will undergo reversible PVE before major hepatic resection.

Procedure: Selective reversible portal vein embolization

Interventions

Selective reversible portal vein embolization 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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Antoine Béclère

Clamart, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single-arm feasibility study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Reversible Portal vein embolization (PVE) using curaspon® (Absorbable Gelatin Hemostats)

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 26, 2016
• Study Start: January 15, 2018
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)