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

Léon Bérard Center

Status

Terminated

Conditions

Liver Metastasis

Treatments

Device: Pre-coagulation of the liver parenchyma with HIFU

Study type

Interventional

Funder types

Other

Identifiers

NCT02728167

HIFU-AR

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.