Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM) : protocol for a prospective, randomised, non-controlled, multicentre study
© 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..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
BMJ open - 9(2019), 12 vom: 03. Dez., Seite e028518 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lin, Jia-Yun [VerfasserIn] |
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| Links: |
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| Themen: |
Biofluid mechanics |
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| Anmerkungen: |
Date Completed 06.10.2020 Date Revised 06.10.2020 published: Electronic ClinicalTrials.gov: NCT03470389 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2018-028518 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM303983140 |
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| 245 | 1 | 0 | |a Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM) |b protocol for a prospective, randomised, non-controlled, multicentre study |
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| 500 | |a ClinicalTrials.gov: NCT03470389 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 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. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT03470389 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a biofluid mechanics | |
| 650 | 4 | |a hepatic venous pressure gradient | |
| 650 | 4 | |a liver cirrhosis | |
| 650 | 4 | |a noninvasive | |
| 650 | 4 | |a portal hypertension | |
| 700 | 1 | |a Zhang, Chi-Hao |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Lei |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Hong-Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Yi-Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Xiao |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Ming-Zhe |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Sun-Hu |e verfasserin |4 aut | |
| 700 | 1 | |a Qi, Xiao-Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Huo, Hai-Zhong |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Hui-Song |e verfasserin |4 aut | |
| 700 | 1 | |a Lou, Xiao-Lou |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Meng |e verfasserin |4 aut | |
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