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.
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
- Conditions the study is for
- Tissue and Organ Harvesting, Liver Transplantation, Brain Death
- 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
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 group | Role | What they receive |
|---|---|---|
| Fibroscan | Experimental | 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 Receives: Procedure: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted2 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completion9 Nov 2017
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue and Organ HarvestingStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas PICHON, MD, Principal investigator, University Hospital, Limoges
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death
- ClinicalTrials.gov ID
- NCT02460250
- Acronym / sponsor ID
- FIBROSCAME / I12033 FIBROSCAME
- Keywords
- Tissue and Organ Harvesting, Liver graft, Brain Death, FibroScan®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroscan | Experimental | Procedure: FibroscanAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanAll 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. | Procedure or surgery | Fibroscan |
Primary outcome
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).
13 secondary outcomes
Liver Stiffness (LS) measurement
Time frame: 1 Day
Controlled Attenuation Parameter™ (CAP™) measurement
Time frame: 1 week
Liver Stiffness (LS) measurement
Time frame: 1 week
Liver Stiffness (LS) measurement
Time frame: 1 month
Controlled Attenuation Parameter™ (CAP™) measurement
Time frame: 1 month
Liver Stiffness (LS) measurement
Time frame: 1 year
Controlled Attenuation Parameter™ (CAP™) measurement
Time frame: 1 year
Fibrosis measurement
Time frame: 1 Day
Steatosis measurement
Time frame: 1 Day
Fibrosis measurement
Time frame: 1 month
Steatosis measurement
Time frame: 1 month
Fibrosis measurement
Time frame: 1 year
Steatosis measurement
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas PICHON, MD principal investigator
University Hospital, Limoges
19 sites in 1 country: see every site and its status.
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.