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

Who is this study for? Adults with Liver Metastasis Colon Cancer
What treatments are being studied? Liver Preparation before Major Hepatectomy
Status: Completed
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU d'Angers
Angers
Bordeaux University Hospital
Bordeaux
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
Centre Léon Berard
Lyon
Hospices Civils de Lyon
Lyon
CHU de Montpellier
Montpellier
CHU de Nice
Nice
APHP - Cochin hospital
Paris
CHU de Poitiers
Poitiers
Hôpital Paul Brousse
Villejuif
Institut Gustave Roussy
Villejuif
Time Frame
Start Date: 2019-04-29
Completion Date: 2024-10-10
Participants
Target number of participants: 64
Treatments
Active_comparator: portal vein embolization
Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
Experimental: liver venous deprivation
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.
Sponsors
Collaborators: Federation Francophone de Cancerologie Digestive
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov