Clinical trial · Interventional
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
NCT03841305CI-TRIAL-00084297HYPER-LIV01completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastasis Colon Cancer | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver preparation before major hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- portal vein embolization
- description
- Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
- interventionNames
- Procedure: Liver preparation before major hepatectomy
- type
- EXPERIMENTAL
- label
- liver venous deprivation
- 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.
- interventionNames
- Procedure: Liver preparation before major hepatectomy
Primary outcomes (1)
- measure
- increase in volume of the future remnant liver (FRL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDeshayes 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 32560632