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

Not Applicable

Terminated

• Conditions: Liver Metastasis
• Interventions: Device: Pre-coagulation of the liver parenchyma with HIFU

• Registration Number: NCT02728167
• Lead Sponsor: Centre Leon Berard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-30
• Study Start: 2016-04
• Study First Posted: 2016-04-05
• Primary Completion: 2018-07
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-coagulation by HIFU-AR	Pre-coagulation of the liver parenchyma with HIFU	Pre-coagulation of the liver parenchyma with HIFU and standard liver resection

Primary Outcome Measures

Name	Time	Method
Normalized blood loss (ml/cm2)	During hepatectomy	To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France