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BMJ Open ; 9(12): e028518, 2019 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-31796472

RESUMO

INTRODUCTION: Portal hypertension (PH) is a severe disease with a poor outcome. Hepatic venous pressure gradient (HVPG), the current gold standard to detect PH, is available only in few hospitals due to its invasiveness and technical difficulty. This study aimed to establish and assess a novel model to calculate HVPG based on biofluid mechanics. METHODS AND ANALYSIS: This is a prospective, randomised, non-controlled, multicentre trial. A total of 248 patients will be recruited in this study, and each patient will undergo CT, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients). The researchers will establish and improve the HVPG using biofluid mechanics (HVPGBFM)model in the original cohort and assess the model in the validation cohort. ETHICS AND DISSEMINATION: The study was approved by the Scientific Research Projects Approval Determination of Independent Ethics Committee of Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (approval number 2017-430 T326). Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03470389.


Assuntos
Velocidade do Fluxo Sanguíneo/fisiologia , Hipertensão Portal/diagnóstico , Veia Porta/diagnóstico por imagem , Pressão Venosa/fisiologia , Pesquisa Biomédica , Compartimentos de Líquidos Corporais , Feminino , Humanos , Hipertensão Portal/diagnóstico por imagem , Testes de Função Hepática/métodos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados não Aleatórios como Assunto , Estudos Prospectivos , Ultrassonografia Doppler
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