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

Primary Purpose

Liver Metastasis

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pre-coagulation of the liver parenchyma with HIFU

About this trial

This is an interventional treatment trial for Liver Metastasis focused on measuring Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Centre Léon Bérard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-coagulation by HIFU-AR

Standard liver resection

Arm Description

Pre-coagulation of the liver parenchyma with HIFU and standard liver resection

Standard liver resection

Outcomes

Primary Outcome Measures

Normalized blood loss (ml/cm2)

To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection

Secondary Outcome Measures

Total blood los (ml)

Transection time

Transection time/cm2 of liver area (min/cm2)

Hemostasis time

Clip density on the liver section area

Number of clips/cm2

Rate of Pringle manoeuvre

Rate of patients needing a blood transfusion

Length of hospital stay

Number of patients with postoperative complications assessed using Dindo-Clavien classification

Full Information

NCT ID

NCT02728167

First Posted

March 22, 2016

Last Updated

August 13, 2018

Sponsor

Centre Leon Berard

1. Study Identification

Unique Protocol Identification Number

NCT02728167

Brief Title

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

Acronym

HIFU-AR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual

Study Start Date

April 2016 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Leon Berard

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastasis

Keywords

Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-coagulation by HIFU-AR

Arm Type

Experimental

Arm Description

Pre-coagulation of the liver parenchyma with HIFU and standard liver resection

Arm Title

Standard liver resection

Arm Type

No Intervention

Arm Description

Standard liver resection

Intervention Type

Device

Intervention Name(s)

Pre-coagulation of the liver parenchyma with HIFU

Intervention Description

6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments

Primary Outcome Measure Information:

Title

Normalized blood loss (ml/cm2)

Description

To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection

Time Frame

During hepatectomy

Secondary Outcome Measure Information:

Title

Total blood los (ml)

Time Frame

During hepatectomy

Title

Transection time

Time Frame

During hepatectomy

Title

Transection time/cm2 of liver area (min/cm2)

Time Frame

During hepatectomy

Title

Hemostasis time

Time Frame

During hepatectomy

Title

Clip density on the liver section area

Description

Number of clips/cm2

Time Frame

During hepatectomy

Title

Rate of Pringle manoeuvre

Time Frame

During hepatectomy

Title

Rate of patients needing a blood transfusion

Time Frame

During hepatectomy

Title

Length of hospital stay

Time Frame

10 days

Title

Number of patients with postoperative complications assessed using Dindo-Clavien classification

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel RIVOIRE, MD, PhD

Organizational Affiliation

Centre Leon Bérard

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69373

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28166812

Citation

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.

Results Reference

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

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