Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM)
NCT ID: NCT03470389
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-03-20
2020-09-30
Brief Summary
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Detailed Description
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1. Establishment and improvement of the HVPGBFM model: For 100 patients in the original cohort, biofluid mechanics specialists will use each patient's computed tomography, blood tests, Doppler ultrasound and HVPG results to adjust the parameters of the HVPGBFM model in order to make each patient's HVPGBFM and HVPG values match well.
2. Assessment of the HVPGBFM model: For 100 patients in the validation cohort, biofluid mechanics specialists will use each patient's computed tomography, blood tests and Doppler ultrasound results to calculate each patient's HVPGBFM according to the HVPGBFM model established previously. Biofluid mechanics specialists will make no changes to the HVPGBFM model and will have no access to patients' HVPG results in this cohort. Finally, the researchers will compare each patient's HVPGBFM and HVPG value and make an assessment of the HVPGBFM model.
Each patient's HVPG measurement will be performed after finishing computed tomography, blood tests and Doppler ultrasound. These results and other clinical data will be inaccessible to professionals for HVPG measurements in order to prevent certain biases. Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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HVPG
Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
HVPG measurement
Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
Interventions
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HVPG measurement
Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.
Exclusion Criteria
* Patients who are medically unstable, terminally or seriously ill, or patients whose clinical course is unpredictable.
* Patients with clinically unstable cardiac disease, for example: congenital heart defect, arrhythmia, uncontrolled heart failure (NYHA Class IV).
* Patients with respiratory distress syndrome or clinically unstable pulmonary disease, for example: pulmonary hypertension, pulmonary emboli, pulmonary vasculitis, emphysema.
* Patients with severe coagulation disorders.
* Patients with unstable occlusive disease or thrombosis within the hepatic, portal, or mesenteric veins.
* Patients who are allergic to iodinated contrast.
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Jiayun Lin
Investigator
Principal Investigators
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Meng Luo
Role: STUDY_CHAIR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jiayun Lin
Role: primary
References
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Lin JY, Zhang CH, Zheng L, Li HJ, Zhu YM, Fan X, Li F, Xia Y, Huang MZ, Yang SH, Qi XL, Huo HZ, Chen HS, Lou XL, Luo M. Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study. BMJ Open. 2019 Dec 3;9(12):e028518. doi: 10.1136/bmjopen-2018-028518.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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JYLJ021
Identifier Type: -
Identifier Source: org_study_id