Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death (FIBROSCAME)

October 23, 2019 updated by: University Hospital, Limoges

According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012).

According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in the obese population. Steatosis results mostly from alcohol consumption and from metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain medications. NAFLD involves up to 30% of the population in Western countries and its prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly, the improvement of liver grafts selection based on objective quantitative criteria which takes into account the degree of liver steatosis appears crucial to increase the number of hepatic transplants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Medical procedure: Fibroscan® based on vibration control transient elastography (VCTETM) with evaluation of controlled attenuation parameter (CAP™) by ultrasounds (Echosens, Paris, France).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
740

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • University Hospital
      • Angers, France, 49100
        • University Hospital
      • Besançon, France, 25030
        • University Hospital
      • Bordeaux, France, 33000
        • University Hospital
      • Brest, France, 29200
        • University Hospital
      • Caen, France, 14033
        • University Hospital
      • Clermont Ferrand, France, 63100
        • Estaing University Hospital
      • Creteil, France, 94010
        • AP-HP Henri Mondor
      • Grenoble, France, 38043
        • University Hospital
      • Lille, France, 59037
        • University Hospital
      • Limoges, France, 87042
        • University Hospital
      • Lyon, France, 69004
        • Croix Rousse Hospital
      • Nice, France, 06000
        • Nice University Hospital
      • Paris, France, 84270
        • AP-HP Kremlin Bicetre
      • Poitiers, France, 86021
        • University Hospital
      • Reims, France, 51100
        • Univesity hospital
      • Rennes, France, 35033
        • University Hospital
      • Tours, France, 37044
        • University Hospital
      • Vandoeuvre-les-nancy, France, 54500
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years with recognized clinical brain death confirmed by clinical examination, who are considered for organ retrieval and clinically stable to achieve the retrieval procedure

Exclusion Criteria:

  • Personal objection to organ retrieval and clinical research expressed during lifetime and registered in the Registre National des Refus (French registration of all refusals to organ donation)
  • Family objection to liver retrieval after donor's death
  • Ongoing pregnancy when brain death is declared
  • For FT and ST measurements included in the panel FibroMaxTM, 4 exclusion criteria are defined specifically (Acute hepatitis or cytolysis with ALT higher than 622 IU/L, acute or chronic hemolysis, extrahepatic cholestasis, sepsis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fibroscan
All included patients will undergo a Fibroscan (either Fibroscan Touch model or 402 model which enable CAPTM data extraction) once all eligibility criteria have been checked. Liver recipients will be followed up during one year. Biological and medical data used by all transplant sites for the follow-up of transplant patient will be collected
Procedure: Fibroscan
All included patients will undergo a Fibroscan (either Fibroscan Touch model or 402 model which enable CAPTM data extraction) once all eligibility criteria have been checked.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Controlled Attenuation Parameter™ (CAP™) measurement
Time Frame: 1 Day
Evaluation of the diagnostic accuracy of the CAP™ measured with Fibroscan® to objectively reflect the degree of liver steatosis, a parameter which can be used as an aid in selecting liver grafts before retrieval in donors with brain death (DBD).
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver Stiffness (LS) measurement
Time Frame: 1 Day
Evaluation of the diagnostic accuracy of LS measured with Fibroscan® to objectively reflect the degree of fibrosis and steatosis, a parameter which can be used as an aid in selecting liver grafts before retrieval in DBD
1 Day
Controlled Attenuation Parameter™ (CAP™) measurement
Time Frame: 1 week
Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation
1 week
Liver Stiffness (LS) measurement
Time Frame: 1 week
Determination of the prognostic value of LS in terms of survival of liver grafts at one week after transplantation
1 week
Liver Stiffness (LS) measurement
Time Frame: 1 month
Determination of the prognostic value of LS in terms of survival of liver grafts at one month after transplantation
1 month
Controlled Attenuation Parameter™ (CAP™) measurement
Time Frame: 1 month
Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one month after transplantation
1 month
Liver Stiffness (LS) measurement
Time Frame: 1 year
Determination of the prognostic value of LS in terms of survival of liver grafts at one week, one month and one year after transplantation
1 year
Controlled Attenuation Parameter™ (CAP™) measurement
Time Frame: 1 year
Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week, one month and one year after transplantation
1 year
Fibrosis measurement
Time Frame: 1 Day
evaluate the diagnostic a accuracy of FibroTest in selecting liver grafts before retrieval in DBD by comparing with 1) histological data obtained with liver biopsy (degree of steatosis, degree of fibrosis) and with 2) CAPTM/LS
1 Day
Steatosis measurement
Time Frame: 1 Day
evaluate the diagnostic a accuracy of SteatoTest in selecting liver grafts before retrieval in DBD by comparing with 1) histological data obtained with liver biopsy (degree of steatosis, degree of fibrosis) and with 2) CAPTM/LS
1 Day
Fibrosis measurement
Time Frame: 1 month
Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one month after transplantation
1 month
Steatosis measurement
Time Frame: 1 month
Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one month after transplantation
1 month
Fibrosis measurement
Time Frame: 1 year
Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one year after transplantation
1 year
Steatosis measurement
Time Frame: 1 year
Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one year after transplantation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Limoges

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas PICHON, MD, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I12033 FIBROSCAME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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