Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e028518.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Lei Zheng |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-97045001054b4defbbbdd707c5080d99 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-97045001054b4defbbbdd707c5080d992025-08-20T02:08:15ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2018-028518Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre studyLei Zheng0Meng Luo1Jia-Yun Lin2Chi-Hao Zhang3Hong-Jie Li4Yi-Ming Zhu5Xiao Fan6Feng Li7Yan Xia8Ming-Zhe Huang9Sun-Hu Yang10Xiao-Liang Qi11Hai-Zhong Huo12Hui-Song Chen13Xiao-Lou Lou14Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USADepartment of Microbiology, Immunology, and Parasitology, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1Prince of Wales Hospital, The Chinese University of Hong Kong (SAR), Imaging and Interventional Radiology, Hong Kong, Hong Kong (SAR)1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China2 Gastroenterology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China1 General Surgery, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, ChinaIntroduction 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.https://bmjopen.bmj.com/content/9/12/e028518.full |
| spellingShingle | 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 Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study BMJ Open |
| title | Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study |
| title_full | Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study |
| title_fullStr | Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study |
| title_full_unstemmed | Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study |
| title_short | Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study |
| title_sort | establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics hvpgbfm protocol for a prospective randomised non controlled multicentre study |
| url | https://bmjopen.bmj.com/content/9/12/e028518.full |
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