Phase
Condition
Neoplasm Metastasis
Treatment
Liver preparation before major hepatectomy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
CHU de Montpellier
Montpellier, Hérault 34295
FranceSite Not Available
CHU d'Angers
Angers, 49933
FranceSite Not Available
Bordeaux University Hospital
Bordeaux,
FranceSite Not Available
CHU de Dijon
Dijon, 21079
FranceSite Not Available
CHU de Grenoble
Grenoble, 38043
FranceSite Not Available
Centre Léon Berard
Lyon, 69373
FranceSite Not Available
Hospices Civils de Lyon
Lyon, 69317
FranceSite Not Available
CHU de Nice
Nice, 06202
FranceSite Not Available
APHP - Cochin hospital
Paris,
FranceSite Not Available
CHU de Poitiers
Poitiers, 80000
FranceSite Not Available
Hôpital Paul Brousse
Villejuif, 94800
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.