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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728167
Recruitment Status : Terminated (Poor accrual)
First Posted : April 5, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Metastasis Device: Pre-coagulation of the liver parenchyma with HIFU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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
Standard liver resection



Primary Outcome Measures :
  1. Normalized blood loss (ml/cm2) [ Time Frame: During hepatectomy ]
    To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection


Secondary Outcome Measures :
  1. Total blood los (ml) [ Time Frame: During hepatectomy ]
  2. Transection time [ Time Frame: During hepatectomy ]
  3. Transection time/cm2 of liver area (min/cm2) [ Time Frame: During hepatectomy ]
  4. Hemostasis time [ Time Frame: During hepatectomy ]
  5. Clip density on the liver section area [ Time Frame: During hepatectomy ]
    Number of clips/cm2

  6. Rate of Pringle manoeuvre [ Time Frame: During hepatectomy ]
  7. Rate of patients needing a blood transfusion [ Time Frame: During hepatectomy ]
  8. Length of hospital stay [ Time Frame: 10 days ]
  9. Number of patients with postoperative complications assessed using Dindo-Clavien classification [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728167


Locations
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France
Centre Léon Bérard
Lyon, France, 69373
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Michel RIVOIRE, MD, PhD Centre Leon Bérard
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02728167    
Other Study ID Numbers: HIFU-AR
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Leon Berard:
Hepatectomy
Liver metastasis
High-Intensity Focused Ultrasound
Liver metastases (LM) requiring surgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases