Diagnostic Role of the Hepatic Venous Pressure Gradient and Elastography in Porto-sinusoidal Vascular Disorder With Portal Hypertension
Hepatic vein pressure gradient measurement
+ Ultrasound-guided percutaneous liver biopsy
+ Multiparametric Abdominal Magnetic Resonance with Elastography
Hipertensión Portal No Cirrótica Idiopática+1
+ Enfermedades del Sistema Digestivo
+ Hipertensión Portal
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de marzo de 2023
Fecha en la que se inscribió al primer participante.Porto-sinusoidal vascular disorder (PSVD) is considered a rare cause of portal hypertension (PH), resulting from specific histological alterations that essentially affect the small portal branches and sinusoids, in the absence of cirrhosis. In recent years, the recognition and importance of PSVD has increased, notably due to the widespread use of transient elastography (TE). However, the definitive diagnosis of PSVD can only be established through liver biopsy. Recent data show that PSVD should be suspected in patients with PH and TE ≤ 20 kPa and liver biopsy should be considered in this context. The investigators hypothesize that hepatic venous pressure gradient (HVPG) and magnetic resonance liver elastography (MRE) may help in the selection of liver biopsy candidates for the diagnosis of PSVD. Primary objectives are: * To describe the measurement of the hepatic venous pressure gradient (in mmHg) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa. * To describe hepatic (in kPa) and splenic (in kPa) stiffness measured by magnetic resonance elastography in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa. * To describe the frequency of major histological findings for the diagnosis of portal sinusoidal vascular disorder (obliterative portal venopathy, regenerative nodular hyperplasia and incomplete septal cirrhosis) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa. Secondary objectives are: * To describe the frequency of hepatic vein-to-vein communications in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa. * To describe the frequency of minor histological findings for the diagnosis of portal sinusoidal vascular disease (portal tract abnormalities, architectural disturbances, nonzonal sinusoidal dilatation, mild perisinusoidal fibrosis) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa. * To compare the serum values of von Willebrand antigen factor (IU/mL) between patients diagnosed with porto-sinusoidal vascular disorder and those diagnosed with cirrhosis, after analysis of liver biopsy. * To compare the serum titers of procollagen III amino-terminal peptide (mcg/l) between patients diagnosed with portosinusoidal vascular disorder and those diagnosed with cirrhosis, after analysis of liver biopsy. * To compare the serum titers of anti-endothelial cell antibodies between patients diagnosed with portosinusoidal vascular disorder and those diagnosed with cirrhosis, after analysis of liver biopsy. 50 patients will be included, prospectively and retrospectively, in a comparative study between diagnostic methods, with a cross-sectional design.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Age ≥ 18 years; * Patients with specific signs of portal hypertension: 1. Endoscopic: esophagogastric/ectopic varices; 2. On imaging (US, CT or MRI): portosystemic collateral veins; * Transient hepatic elastography with valid values ≤ 20 kPa; * Signed written informed consent form. Exclusion Criteria: * Contraindications to HVPG or percutaneous liver biopsy: 1. Pregnancy 2. Allergy to iodine 3. Chronic kidney disease with creatinine clearance \< 50 ml/min 4. Anticoagulation 5. RNI \> 1.5 6. Platelets \< 50,000/mm3 * Confounding factors: 1\. Hepatitis C treated with SVR * Conditions that exclude the diagnosis of PSVD: 1. History of bone marrow transplant 2. Budd-Chiari 3. Congestive heart failure or Fontan surgery 4. Abernethy's Syndrome 5. Hereditary hemorrhagic telangiectasia 6. Chronic cholestatic diseases 7. Neoplastic hepatic infiltration 8. Sarcoidosis 9. Congenital hepatic fibrosis 10. Hepatosplenic schistosomiasis 11. Portal cavernoma / thrombosis with complete occlusion of the main portal vein.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Hospital Universitário Clementino Fraga Filho / Universidade Federal do Rio de Janeiro (UFRJ)
Rio de Janeiro, BrazilAbrir Hospital Universitário Clementino Fraga Filho / Universidade Federal do Rio de Janeiro (UFRJ) en Google Maps