Status:
COMPLETED
Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Federation Francophone de Cancerologie Digestive
Conditions:
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 liv...
Detailed Description
Portal vein embolization (PVE) has been widely used to generate hypertrophy of the nonembolized lobe in patients undergoing major hepatectomy in order to prevent small-for-size remnant liver resulting...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria
- Patient with cirrhosis
- Presence of clinical ascites
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03841305
Start Date
April 29 2019
End Date
October 10 2024
Last Update
January 3 2025
Active Locations (12)
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1
CHU de Montpellier
Montpellier, Hérault, France, 34295
2
CHU d'Angers
Angers, France, 49933
3
Bordeaux University Hospital
Bordeaux, France
4
CHU de Dijon
Dijon, France, 21079