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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02460250
Acronym
FIBROSCAME
Enrollment
740
Registered
2015-06-02
Start date
2015-02-28
Completion date
2018-11-09
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death, Liver Transplantation, Tissue and Organ Harvesting

Keywords

Tissue and Organ Harvesting, Liver graft, Brain Death, FibroScan®

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.

Detailed description

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

Interventions

PROCEDUREFibroscan

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.

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Controlled Attenuation Parameter™ (CAP™) measurement1 DayEvaluation 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

MeasureTime frameDescription
Liver Stiffness (LS) measurement1 DayEvaluation 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
Controlled Attenuation Parameter™ (CAP™) measurement1 weekDetermination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation
Fibrosis measurement1 Dayevaluate 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
Steatosis measurement1 Dayevaluate 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026