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

NCT02728167 | Terminated DMC

• 1 other identifier: HIFU-AR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  During hepatectomy

Study Arms (2)

Pre-coagulation by HIFU-AR

EXPERIMENTAL

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

Device: Pre-coagulation of the liver parenchyma with HIFU

Standard liver resection

NO INTERVENTION

Standard liver resection

Interventions

Pre-coagulation of the liver parenchyma with HIFU DEVICE

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

Pre-coagulation by HIFU-AR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (1)

• 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.

  PMID: 28166812 DERIVED

Study Officials

• Michel RIVOIRE, MD, PhD

  Centre Leon Bérard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 5, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)