NCT03841305

Brief Summary

The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5.5 years

First QC Date

February 13, 2019

Last Update Submit

January 2, 2025

Conditions

Liver Metastasis Colon Cancer

Keywords

LiverInterventional radiologyPortal vein embolizationPortal and hepatic vein embolizationFuture liver remnantSurgeryNon-cirrhotic liverLiver metastasesColorectal cancerLiver RegenerationLiver resection

Outcome Measures

Primary Outcomes (1)

  • increase in volume of the future remnant liver (FRL)

    The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)

    at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan

Secondary Outcomes (15)

  • Tolerance

    between the day of liver preparation and 90 days after surgery

  • Post-operative mortality

    90 days after surgery

  • Post-operative morbidity

    90 days after surgery

  • Post-hepatectomy liver failure

    between the day of the surgery and 90 days after surgery

  • Rate of non-resectability due to insufficient FRL

    between the day of the treatment and the day of the surgery

  • +10 more secondary outcomes

Study Arms (2)

portal vein embolization

ACTIVE COMPARATOR

Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

Procedure: Liver preparation before major hepatectomy

liver venous deprivation

EXPERIMENTAL

Liver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.

Procedure: Liver preparation before major hepatectomy

Interventions

Liver preparation before major hepatectomyPROCEDURE

Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.

liver venous deprivationportal vein embolization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver metastases from colo-rectal origin considered as resectable (as validated by a multidisciplinary committee with at least one senior hepatic surgeon) provided sufficient FRL volume
  • Percentage of FRL volume \< 30%
  • Age ≥ 18 years
  • General health status World Health Organisation 0,1
  • Estimated life expectancy \> 3 months
  • Patients whose biological parameters are :
  • Platelets ≥100,000/mm3,
  • Polynuclear neutrophils ≥ 1000/mm3,
  • Hemoglobin≥ 9g/dL (even transfused patients can be included)
  • Creatininemia \< 1.5 times the normal value
  • Creatinine clearance \> 30 milliliters (mL)/min
  • Bilirubinemia ≤ 1,5 times the normal value
  • liver transaminases ≤ 5 times the normal value
  • prothrombin rate \> 70%
  • Reference liver CT-Scan or MRI done during the 30 days preceding PVE or LVD.
  • +2 more criteria

You may not qualify if:

  • Patient with cirrhosis
  • Presence of clinical ascites
  • Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment
  • Pregnancy (betaHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age
  • Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
  • Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients)
  • Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 48 hours
  • Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix
  • Legal incapacity (persons in custody or under guardianship)
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Montpellier

Montpellier, Hérault, 34295, France

Location

CHU d'Angers

Angers, 49933, France

Location

Bordeaux University Hospital

Bordeaux, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hospices Civils de Lyon

Lyon, 69317, France

Location

Centre Léon Berard

Lyon, 69373, France

Location

CHU de Nice

Nice, 06202, France

Location

APHP - Cochin hospital

Paris, France

Location

CHU de Poitiers

Poitiers, 80000, France

Location

Hôpital Paul Brousse

Villejuif, 94800, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

  • Deshayes E, Piron L, Bouvier A, Lapuyade B, Lermite E, Vervueren L, Laurent C, Pinaquy JB, Chevallier P, Dohan A, Rode A, Sengel C, Guillot C, Quenet F, Guiu B. Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases. BMC Cancer. 2020 Jun 19;20(1):574. doi: 10.1186/s12885-020-07065-z.

    PMID: 32560632DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 15, 2019

Study Start

April 29, 2019

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

January 3, 2025

Record last verified: 2025-01

Locations

FR(12)