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

23 de octubre de 2019 actualizado por: University Hospital, Limoges

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

740

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
      • Amiens, Francia, 80054
        • University Hospital
      • Angers, Francia, 49100
        • University Hospital
      • Besançon, Francia, 25030
        • University Hospital
      • Bordeaux, Francia, 33000
        • University Hospital
      • Brest, Francia, 29200
        • University Hospital
      • Caen, Francia, 14033
        • University Hospital
      • Clermont Ferrand, Francia, 63100
        • Estaing University Hospital
      • Creteil, Francia, 94010
        • AP-HP Henri Mondor
      • Grenoble, Francia, 38043
        • University Hospital
      • Lille, Francia, 59037
        • University Hospital
      • Limoges, Francia, 87042
        • University Hospital
      • Lyon, Francia, 69004
        • Croix Rousse Hospital
      • Nice, Francia, 06000
        • Nice University Hospital
      • Paris, Francia, 84270
        • AP-HP Kremlin Bicetre
      • Poitiers, Francia, 86021
        • University Hospital
      • Reims, Francia, 51100
        • Univesity hospital
      • Rennes, Francia, 35033
        • University Hospital
      • Tours, Francia, 37044
        • University Hospital
      • Vandoeuvre-les-nancy, Francia, 54500
        • University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Controlled Attenuation Parameter™ (CAP™) measurement
Periodo de tiempo: 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).
1 Day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Liver Stiffness (LS) measurement
Periodo de tiempo: 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
1 Day
Controlled Attenuation Parameter™ (CAP™) measurement
Periodo de tiempo: 1 week
Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation
1 week
Liver Stiffness (LS) measurement
Periodo de tiempo: 1 week
Determination of the prognostic value of LS in terms of survival of liver grafts at one week after transplantation
1 week
Liver Stiffness (LS) measurement
Periodo de tiempo: 1 month
Determination of the prognostic value of LS in terms of survival of liver grafts at one month after transplantation
1 month
Controlled Attenuation Parameter™ (CAP™) measurement
Periodo de tiempo: 1 month
Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one month after transplantation
1 month
Liver Stiffness (LS) measurement
Periodo de tiempo: 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
1 year
Controlled Attenuation Parameter™ (CAP™) measurement
Periodo de tiempo: 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
1 year
Fibrosis measurement
Periodo de tiempo: 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
1 Day
Steatosis measurement
Periodo de tiempo: 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
1 Day
Fibrosis measurement
Periodo de tiempo: 1 month
Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one month after transplantation
1 month
Steatosis measurement
Periodo de tiempo: 1 month
Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one month after transplantation
1 month
Fibrosis measurement
Periodo de tiempo: 1 year
Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one year after transplantation
1 year
Steatosis measurement
Periodo de tiempo: 1 year
Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one year after transplantation
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Limoges

Investigadores

  • Investigador principal: Nicolas PICHON, MD, University Hospital, Limoges

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2015

Finalización primaria (Actual)

9 de noviembre de 2017

Finalización del estudio (Actual)

9 de noviembre de 2018

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2015

Publicado por primera vez (Estimar)

2 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de octubre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

23 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • I12033 FIBROSCAME

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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