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
- Diseases
- Colorectal cancer
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Bordeaux University Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| APHP - Cochin hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Hôpital Paul-Brousse Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.