Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant (HYPER-LIV01)

University Hospital Center (CHU)

Status and phase: Completed; Phase 2

Conditions: Liver Metastasis Colon Cancer

Treatments: Procedure: Liver preparation before major hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03841305

RECHMPL18_0025

UF 7595 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

portal vein embolization

Active Comparator group

Description:

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

Treatment:

Procedure: Liver preparation before major hepatectomy

liver venous deprivation

Experimental group

Description:

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.

Treatment:

Procedure: Liver preparation before major hepatectomy