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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Metastasis
• Intervention / Treatment: Device: Pre-coagulation of the liver parenchyma with HIFU

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69373
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Length of hospital stay		10 days
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
Number of patients with postoperative complications assessed using Dindo-Clavien classification		6 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Michel RIVOIRE, MD, PhD, Centre Léon Bérard

Publications and helpful links

General Publications

• Dupre A, Perol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Hepatectomy; High-Intensity Focused Ultrasound; Liver metastasis; Liver metastases (LM) requiring surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: HIFU-AR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO