- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02530567
Non-invasive Evaluation of Portal Pressure by MRI (ENIP)
Using MRI for a Non-invasive Evaluation of Portal Pressure
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
All patients will benefit from:
- Pressure gradient measurement portosystemic
- MRI measurement of azygos flow, aortic, portals, spleen and lower cellar
- Liver biopsy
- Laboratory tests
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Toulouse, Francia, 31059
- Uh Toulouse
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Suspicion of chronic liver disease
- Indication to perform a liver biopsy transjugular
- Patient able to consent
Exclusion Criteria:
- contraindication to MRI:
- Holders of a pacemaker or a defibrillator, an implanted material activated by electrical, magnetic or mechanical
- Holders of hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants
- claustrophobic
- Severe hepatic encephalopathy
- Inability to MRI in the week surrounding the first jugular
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention
The measurement of portosystemic pressure gradient will be performed before liver biopsy. Then liver biopsy is performed. The MRI was performed on the day of biopsy or within one week around the completion of the biopsy. The MRI machine used is the Siemens 3T. |
All patients performing the biopsy will have an MRI to carry out the necessary measures.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.
Periodo de tiempo: 1 week
|
MRI and catheterization will be performed the same week. For the azygos blood flow (by MRI), measures will be repeated 5 times. Speed of extraction and the rate on the post processing console will be made with a double reading. For the measurement of portal pressure by catheterization, will be performed measurements of occluded hepatic vein pressure and free hepatic vein. They will be repeated 3 times each. These measures will be carried out to calculate the portosystemic pressure gradient. The flow rate and gradient measurements will be performed blindly to the other. |
1 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.
Periodo de tiempo: 1 week
|
This outcome is different of primary outcome because the Measurement of azygos blood flow (MRI) is repeated on a strictly perpendicular section to the vessel facing the T4-T5 disk and the extraction speed rate and on post processing console is made by double reading. Measuring portal pressure by catheterization. Measurements of occluded hepatic vein pressure and free hepatic vein and will be repeated 3 times each. Flow measurements and gradient will be carried out blind to each other by the radiologist and the hepatologist. |
1 week
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Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.
Periodo de tiempo: 1 week
|
Measurement of azygos blood flow (MRI) Repeated Measure 5 times on a strictly perpendicular cut to the vessel immediately after anastomosis of the hepatic veins to the inferior vena cava and Extraction speed and flow on post processing console with double reading. Measurement of portal pressure by catheterization It will be defined by the measures of occluded hepatic vein pressure and free hepatic vein and measurements will be repeated 3 times each. The flow rate and gradient measurements will be performed blindly to the other. |
1 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Phillipe OTAL, MD, Uh Toulouse
Publicaciones y enlaces útiles
Publicaciones Generales
- Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
- Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.
- Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2.
- Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC31/14/7318
- University Hospital Toulouse (Otro número de subvención/financiamiento: 14731802)
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