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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT02460250
Collaborator
(none)
740
19
1
45.2
38.9
0.9

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fibroscan
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Nov 9, 2017
Actual Study Completion Date :
Nov 9, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Controlled Attenuation Parameter™ (CAP™) measurement [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).

Secondary Outcome Measures

  1. Liver Stiffness (LS) measurement [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

  2. Controlled Attenuation Parameter™ (CAP™) measurement [1 week]

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

  3. Liver Stiffness (LS) measurement [1 week]

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

  4. Liver Stiffness (LS) measurement [1 month]

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

  5. Controlled Attenuation Parameter™ (CAP™) measurement [1 month]

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

  6. Liver Stiffness (LS) measurement [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

  7. Controlled Attenuation Parameter™ (CAP™) measurement [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

  8. Fibrosis measurement [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

  9. Steatosis measurement [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

  10. Fibrosis measurement [1 month]

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

  11. Steatosis measurement [1 month]

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

  12. Fibrosis measurement [1 year]

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

  13. Steatosis measurement [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Amiens France 80054
2 University Hospital Angers France 49100
3 University Hospital Besançon France 25030
4 University Hospital Bordeaux France 33000
5 University Hospital Brest France 29200
6 University Hospital Caen France 14033
7 Estaing University Hospital Clermont Ferrand France 63100
8 AP-HP Henri MONDOR Creteil France 94010
9 University Hospital Grenoble France 38043
10 University Hospital Lille France 59037
11 University Hospital Limoges France 87042
12 Croix Rousse Hospital Lyon France 69004
13 Nice University Hospital Nice France 06000
14 AP-HP Kremlin Bicêtre Paris France 84270
15 University Hospital Poitiers France 86021
16 Univesity Hospital Reims France 51100
17 University Hospital Rennes France 35033
18 University Hospital Tours France 37044
19 University Hospital Vandoeuvre-les-nancy France 54500

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

  • Principal Investigator: Nicolas PICHON, MD, University Hospital, Limoges

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT02460250
Other Study ID Numbers:
  • I12033 FIBROSCAME
First Posted:
Jun 2, 2015
Last Update Posted:
Oct 24, 2019
Last Verified:
Oct 1, 2019
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2019