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Tissue and Organ HarvestingFIBROSCAMENCT02460250

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

A study testing Fibroscan in people with Tissue and Organ Harvesting and Liver Transplantation, run by University Hospital, Limoges at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fibroscan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
19 sitesFrance
Study dates
Feb 2015to 9 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites
  • University Hospital

    Amiens, 80054

  • University Hospital

    Angers, 49100

  • University Hospital

    Besançon, 25030

  • University Hospital

    Bordeaux, 33000

  • University Hospital

    Brest, 29200

  • University Hospital

    Caen, 14033

  • Estaing University Hospital

    Clermont-Ferrand, 63100

  • AP-HP Henri MONDOR

    Créteil, 94010

  • University Hospital

    Grenoble, 38043

  • University Hospital

    Lille, 59037

  • University Hospital

    Limoges, 87042

  • Croix Rousse Hospital

    Lyon, 69004

  • Nice University Hospital

    Nice, 06000

  • AP-HP Kremlin Bicêtre

    Paris, 84270

  • University Hospital

    Poitiers, 86021

  • Univesity Hospital

    Reims, 51100

  • University Hospital

    Rennes, 35033

  • University Hospital

    Tours, 37044

  • University Hospital

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

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.

Read the detailed description

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

Being tested
Fibroscan
Keywords
Tissue and Organ Harvesting, Liver graft, Brain Death, FibroScan®
Medical subject headings
Brain Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibroscanProcedure or surgery

    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.

Study groups in NCT02460250
Study groupRoleWhat they receive
FibroscanExperimentalAll 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
Receives: Procedure: Fibroscan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Controlled Attenuation Parameter™ (CAP™) measurement

    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).

    Measured: 1 Day

Secondary outcomes (13)
  1. Liver Stiffness (LS) measurement

    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

    Measured: 1 Day

  2. Controlled Attenuation Parameter™ (CAP™) measurement

    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation

    Measured: 1 week

  3. Liver Stiffness (LS) measurement

    Determination of the prognostic value of LS in terms of survival of liver grafts at one week after transplantation

    Measured: 1 week

  4. Liver Stiffness (LS) measurement

    Determination of the prognostic value of LS in terms of survival of liver grafts at one month after transplantation

    Measured: 1 month

  5. Controlled Attenuation Parameter™ (CAP™) measurement

    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one month after transplantation

    Measured: 1 month

  6. Liver Stiffness (LS) measurement

    Determination of the prognostic value of LS in terms of survival of liver grafts at one week, one month and one year after transplantation

    Measured: 1 year

  7. Controlled Attenuation Parameter™ (CAP™) measurement

    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week, one month and one year after transplantation

    Measured: 1 year

  8. Fibrosis measurement

    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

    Measured: 1 Day

  9. Steatosis measurement

    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

    Measured: 1 Day

  10. Fibrosis measurement

    Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one month after transplantation

    Measured: 1 month

  11. Steatosis measurement

    Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one month after transplantation

    Measured: 1 month

  12. Fibrosis measurement

    Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one year after transplantation

    Measured: 1 year

  13. Steatosis measurement

    Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one year after transplantation

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion9 Nov 2017
  4. Study completion9 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460250
Sponsor's protocol ID
I12033 FIBROSCAME
Acronym
FIBROSCAME
Status last verified
Oct 2019
First submitted
13 May 2015
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Fibroscan in people with Tissue and Organ Harvesting and Liver Transplantation, run by University Hospital, Limoges at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Controlled Attenuation Parameter™ (CAP™) measurement (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.

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