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NCT03841305CompletedPhase 2

Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant

Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial

Source: ClinicalTrials.gov · Last updated 3 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
64 (actual)
First submitted
13 Feb 2019
Start date
29 Apr 2019
Primary completion date
10 Oct 2024
Lead sponsor
University Hospital, Montpellier
NCT number
NCT03841305

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 64
  • From 29 Apr 2019 to the primary completion date, 10 Oct 2024
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug
  • Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment
  • Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
  • Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 48 hours

Other illness

  • Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients)

Lab values

  • Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix

Age

  • Pregnancy (betaHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age

Other

  • Patient with cirrhosis
  • Presence of clinical ascites
  • 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

Who the study is looking for

  • 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.
  • Written informed consent
  • National health insurance cover

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d Angers
Coordinator of this site? Confirm its status
AngersFranceUnknown status
Bordeaux University Hospital
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHU de DIJON
Coordinator of this site? Confirm its status
DijonFranceUnknown status
CHU de Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
LyonFranceUnknown status
CHU de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU de Nice
Coordinator of this site? Confirm its status
NiceFranceUnknown status
APHP - Cochin hospital
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceUnknown status
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status
Hôpital Paul-Brousse
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.