Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study
Lei Zheng,
Meng Luo,
Jia-Yun Lin,
Chi-Hao Zhang,
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
Affiliations
Lei Zheng
Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Meng Luo
Department of Microbiology, Immunology, and Parasitology, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA
Jia-Yun Lin
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Chi-Hao Zhang
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Hong-Jie Li
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Yi-Ming Zhu
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Xiao Fan
1Prince of Wales Hospital, The Chinese University of Hong Kong (SAR), Imaging and Interventional Radiology, Hong Kong, Hong Kong (SAR)
Feng Li
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Yan Xia
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Ming-Zhe Huang
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Sun-Hu Yang
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Xiao-Liang Qi
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Hai-Zhong Huo
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Hui-Song Chen
2 Gastroenterology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Xiao-Lou Lou
1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
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.
