Clinical Trials

Inclsuion Criteria: 

• Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery. Note: for the pilot phase less extended resections (RLV > 69%) are required)
• Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)
• Remnant Liver Volume to Body Weight ratio (RLVBWR) > 1.
• General health status WHO 0 or 1.
• Estimated life expectancy > 3 months.
• Patients whose preoperative biological parameters are:
  • Platelets ≥ 100,000/mm3
  • Polynuclear neutrophils ≥ 1000/mm3
  • Haemoglobin ≥ 9 g/dL (Post-transfusion patients can be included)
  • Creatinine < 1.5x ULN
  • Bilirubin ≤ 2x ULN f. Albumin > LLN
  • AST and ALT ≤ 5X ULN 7
• Written informed consent.

Exclusion Criteria:

• Liver Cirrhosis
• Preoperative presence of clinical ascites.
• Any other liver cancer.
• BMI > 35 kg/m2
• ASA Score > 4 6. CC Score > 0: all patients with pre-operatively or intraoperatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable are excluded from participation in the study.
• Ongoing participation or participation within the 28 days prior to inclusion in the study in another therapeutic trial with an experimental drug and during FU period post hepatectomy.
• Serious non-stabilized disease, active uncontrolled infection, or other serious underlying disorder likely to prevent the patient from receiving the treatment.
• Pregnancy (βHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age.
• Allergy or contra-indication to iodine contrast agents.
• Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 48 hrs.
• Chemotherapy within the last 30 days pre-operatively.
• Positive testing for HBV/HCV or autoimmune hepatitis
• Incomplete liver metastasis resection.
• 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.
• Specific contraindications against MRI exams.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/01/2024. Questions regarding updates should be directed to the study team contact.