Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-09

Study Completion Date

2020-12-31

Brief Summary

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This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

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Detailed Description

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As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.

Conditions

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Liver Fibrosis Cirrhosis Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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liver fibrosis

liver biopsy proved

hemodynamics tests

Intervention Type DIAGNOSTIC_TEST

Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

portal hypertension

hepatic venous pressure gradient (HVPG) proved

hemodynamics tests

Intervention Type DIAGNOSTIC_TEST

Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

Interventions

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hemodynamics tests

Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Inpatients who undergo liver biopsy or hepatic venous pressure gradient test

Exclusion Criteria

* decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy);
* alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 × upper limit of normal (ULN);
* any malignant tumor;
* any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases;
* severe neurological or psychological disease;
* pregnant or lactating women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No