Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study

Jia-Yun Lin, Chi-Hao Zhang, Lei Zheng, Hong-Jie Li, Yi-Ming Zhu, Xiao Fan, Feng Li, Yan Xia, Ming-Zhe Huang, Sun-Hu Yang, Xiao-Liang Qi, Hai-Zhong Huo, Hui-Song Chen, Xiao-Lou Lou, Meng Luo, Jia-Yun Lin, Chi-Hao Zhang, Lei Zheng, Hong-Jie Li, Yi-Ming Zhu, Xiao Fan, Feng Li, Yan Xia, Ming-Zhe Huang, Sun-Hu Yang, Xiao-Liang Qi, Hai-Zhong Huo, Hui-Song Chen, Xiao-Lou Lou, Meng Luo

Abstract

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.

Keywords: biofluid mechanics; hepatic venous pressure gradient; liver cirrhosis; noninvasive; portal hypertension.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design and procedure. HVPG, hepatic venous pressure gradient; HVPGBFM, hepatic venous pressure gradient using biofluid mechanics.
Figure 2
Figure 2
Ultrasound measurement positions. 1, right branch of the portal vein; 2, left branch of the portal vein; 3, the portal vein; 4, proximal part of the splenic vein; 5, distal part of the splenic vein; 6, the superior mesenteric vein; 7, the inferior mesenteric vein; 8, the right hepatic vein; 9, the middle hepatic vein; 10, the left hepatic vein; 11, the suprahepatic inferior vena cava; 12, the infrahepatic inferior vena cava.
Figure 3
Figure 3
An example of the simulation model of a portal venous system and its body meshes. (A) The simulation model of a portal venous system. (B) The body meshes of the simulation model.
Figure 4
Figure 4
An example of the blood flow velocity (m/s) of the portal vein and its branches.
Figure 5
Figure 5
An example of the blood pressure (Pa) of the portal vein and its branches.
Figure 6
Figure 6
The process of the HVPGBFM computation. HVPG, hepatic venous pressure gradient; HVPGBFM, hepatic venous pressure gradient using biofluid mechanics.

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