Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM) (HVPGBFM)

December 12, 2018 updated by: Jiayun Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200011
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Meng Luo
        • Sub-Investigator:
          • Jiayun Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be at least 18 years of age.
  • Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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 Names:
  • Blood test
  • Computed tomography
  • Doppler ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborators

RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Meng Luo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JYLJ021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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