Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPG<sub>BFM</sub>): protocol for a prospective, randomised, non-controlled, multicentre study.
prospective_cohort · Level II
Where this comes from
- Record sourced from PubMed, PMID 31796472.
- Also identified by DOI 10.1136/bmjopen-2018-028518 and PMC identifier 6926408.
- Licence recorded as CC BY-NC.
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Abstract
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. 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 (HVPG<sub>BFM</sub>)model in the original cohort and assess the model in the validation cohort. 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. NCT03470389.
Medical subject headings
- Blood Flow Velocity
- Hypertension, Portal
- Portal Vein
- Venous Pressure