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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Liver Metastasis

Intervention / Treatment
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* Device: Pre-coagulation of the liver parenchyma with HIFU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-coagulation by HIFU-AR<br>Pre-coagulation of the liver parenchyma with HIFU and standard liver resection | Device: Pre-coagulation of the liver parenchyma with HIFU<br>* 6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments<br>|
| No Intervention: Standard liver resection<br>Standard liver resection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized blood loss (ml/cm2) | To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection | During hepatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood los (ml) |  | During hepatectomy | 
| Transection time |  | During hepatectomy | 
| Transection time/cm2 of liver area (min/cm2) |  | During hepatectomy | 
| Hemostasis time |  | During hepatectomy | 
| Clip density on the liver section area | Number of clips/cm2 | During hepatectomy | 
| Rate of Pringle manoeuvre |  | During hepatectomy | 
| Rate of patients needing a blood transfusion |  | During hepatectomy | 
| Length of hospital stay |  | 10 days | 
| Number of patients with postoperative complications assessed using Dindo-Clavien classification |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery