Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death (FIBROSCAME)
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Amiens、フランス、80054
- University Hospital
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Angers、フランス、49100
- University Hospital
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Besançon、フランス、25030
- University Hospital
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Bordeaux、フランス、33000
- University Hospital
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Brest、フランス、29200
- University Hospital
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Caen、フランス、14033
- University Hospital
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Clermont Ferrand、フランス、63100
- Estaing University Hospital
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Creteil、フランス、94010
- AP-HP Henri Mondor
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Grenoble、フランス、38043
- University Hospital
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Lille、フランス、59037
- University Hospital
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Limoges、フランス、87042
- University Hospital
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Lyon、フランス、69004
- Croix Rousse Hospital
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Nice、フランス、06000
- Nice University Hospital
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Paris、フランス、84270
- AP-HP Kremlin Bicetre
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Poitiers、フランス、86021
- University Hospital
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Reims、フランス、51100
- Univesity hospital
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Rennes、フランス、35033
- University Hospital
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Tours、フランス、37044
- University Hospital
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Vandoeuvre-les-nancy、フランス、54500
- University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Controlled Attenuation Parameter™ (CAP™) measurement
時間枠：1 Day
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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).
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1 Day
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Liver Stiffness (LS) measurement
時間枠：1 Day
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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
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1 Day
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Controlled Attenuation Parameter™ (CAP™) measurement
時間枠：1 week
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Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation
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1 week
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Liver Stiffness (LS) measurement
時間枠：1 week
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Determination of the prognostic value of LS in terms of survival of liver grafts at one week after transplantation
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1 week
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Liver Stiffness (LS) measurement
時間枠：1 month
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Determination of the prognostic value of LS in terms of survival of liver grafts at one month after transplantation
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1 month
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Controlled Attenuation Parameter™ (CAP™) measurement
時間枠：1 month
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Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one month after transplantation
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1 month
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Liver Stiffness (LS) measurement
時間枠：1 year
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Determination of the prognostic value of LS in terms of survival of liver grafts at one week, one month and one year after transplantation
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1 year
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Controlled Attenuation Parameter™ (CAP™) measurement
時間枠：1 year
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Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week, one month and one year after transplantation
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1 year
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Fibrosis measurement
時間枠：1 Day
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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
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1 Day
|
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Steatosis measurement
時間枠：1 Day
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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
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1 Day
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Fibrosis measurement
時間枠：1 month
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Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one month after transplantation
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1 month
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Steatosis measurement
時間枠：1 month
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Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one month after transplantation
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1 month
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Fibrosis measurement
時間枠：1 year
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Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one year after transplantation
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1 year
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Steatosis measurement
時間枠：1 year
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Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one year after transplantation
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1 year
|
協力者と研究者
捜査官
- 主任研究者：Nicolas PICHON, MD、University Hospital, Limoges
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Fibroscanの臨床試験
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Assistance Publique - Hôpitaux de ParisEchosensまだ募集していません
-
University Health Network, Toronto積極的、募集していない
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Fondazione IRCCS Policlinico San Matteo di Pavia完了
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Echosens完了
-
Nanfang Hospital, Southern Medical University募集