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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2022
  • participants needed
    64
  • sponsor
    University Hospital, Montpellier
Updated on 24 January 2021

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.

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 in post-operative liver insufficiency.

Although PVE is a safe and effective procedure, it does not always induce sufficient hypertrophy of the future remnant liver (FRL) even after a long time. In case of insufficient liver regeneration following PVE, some authors suggested to embolize hepatic vein(s) (Hwang, Ann Surg 2009).

Interestingly, the sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FRL. Although attractive, this approach requires two different procedures and does not spare time as compared to PVE alone.

To shorten and optimize the phase of liver preparation before surgery,the so-called liver venous deprivation (LVD) technique that combines both PVE and HVE during the same procedure was developed.

The aim of this randomized phase II trial is to compare the percentage of change in FRL volume at 3 weeks after LVD or PVE using MRI or CT-scan.

Details
Condition Liver Metastasis Colon Cancer
Treatment Liver preparation before major hepatectomy
Clinical Study IdentifierNCT03841305
SponsorUniversity Hospital, Montpellier
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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