Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.

Inclusion Criteria:

• Age ≥ 18 years at the day of consenting to the study.

• Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.

• ECOG PS ≤ 1.

• Adequate bone marrow and liver function at baseline as defined below:

  • Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),
  • Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.

• Recovered from prior anti-neoplasic treatment-related toxicity (grade <2 persistent treatment-related toxicity as per CTCAE v4 are accepted).

• Willingness for follow-up visits.

• Covered by a medical insurance.

• Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

• Patients having previously undergone

  • a major hepatic surgery (i.e. more than 3 liver segments) or
  • biliary major surgery.

• Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.

• Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.