Liver CirrhosisHVPGBFMNCT03470389
Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM)
A study testing HVPG measurement in people with Liver Cirrhosis and Hypertension, Portal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hypertension, Portal
- What is being tested?
- HVPG measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2018to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age.
- Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.
Who cannot join
- Female patients who are pregnant or nursing.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200011
Jiayun Lin, 18017370556, lin_jiayun@outlook.com
Meng Luo
About this study
This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. A total of 200 patients will be recruited in this study and each patient will undergo computed tomography, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (100 patients) and validation cohort (100 patients). The researchers will establish and improve the HVPGBFM model in the original cohort and assess the model in the validation cohort.
Read the detailed description
Consecutive patients are randomly assigned 1:1 to either the original cohort or the validation cohort. Randomization is based on the computer-generated random digits table. This study consists of two independent and consecutive stages:
- 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.
- 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
- Liver Cirrhosis, Hypertension, Portal
- Being tested
- HVPG measurement
- Keywords
- Liver Cirrhosis, Hypertension, Portal, Hepatic Venous Pressure Gradient (HVPG), Biofluid Mechanics, Noninvasive
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVPG measurementProcedure or surgery
Also called Blood test, Doppler ultrasound, Computed tomography
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.
| Study group | Role | What they receive |
|---|---|---|
| HVPG | Experimental | 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. Receives: Procedure: HVPG measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HVPGBFM and HVPG by Bland-Altman plot.
The numeric correlation between HVPGBFM and HVPG will be analysed by using Bland and Altman's limits of agreement analysis.
Measured: 7 days
Correlation between HVPGBFM and HVPG by linear regression analysis.
The numeric relationship between HVPGBFM and HVPG will be analysed by using linear regression analysis.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start20 Mar 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayun Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Meng Luo, Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470389
- Sponsor's protocol ID
- JYLJ021
- Acronym
- HVPGBFM
- Status last verified
- Dec 2018
- First submitted
- 25 Feb 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31796472
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM)
- ClinicalTrials.gov ID
- NCT03470389
- Acronym / sponsor ID
- HVPGBFM / JYLJ021
- Conditions
- Liver Cirrhosis, Hypertension, Portal
- Keywords
- Liver Cirrhosis, Hypertension, Portal, Hepatic Venous Pressure Gradient (HVPG), Biofluid Mechanics, Noninvasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. A total of 200 patients will be recruited in this study and each patient will undergo computed tomography, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (100 patients) and validation cohort (100 patients). The researchers will establish and improve the HVPGBFM model in the original cohort and assess the model in the validation cohort.
Detailed description
Consecutive patients are randomly assigned 1:1 to either the original cohort or the validation cohort. Randomization is based on the computer-generated random digits table. This study consists of two independent and consecutive stages:
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HVPG | Experimental | Procedure: HVPG measurementEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be at least 18 years of age.
- Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.
Key exclusion criteria (7 listed)
- Female patients who are pregnant or nursing.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVPG measurementAlso: Blood test, Doppler ultrasound, Computed tomographyEach 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. | Procedure or surgery | HVPG |
Primary outcome
Correlation between HVPGBFM and HVPG by Bland-Altman plot.
Time frame: 7 days
The numeric correlation between HVPGBFM and HVPG will be analysed by using Bland and Altman's limits of agreement analysis.
Correlation between HVPGBFM and HVPG by linear regression analysis.
Time frame: 7 days
The numeric relationship between HVPGBFM and HVPG will be analysed by using linear regression analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 31796472Lin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Luo study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVPG measurement in people with Liver Cirrhosis and Hypertension, Portal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayun Lin (+86 18017370556, lin_jiayun@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HVPGBFM and HVPG by Bland-Altman plot. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.