Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

Study Overview
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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.

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.

Official Title
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Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension

Conditions
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Liver Fibrosis, Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Diagnostic Test: hemodynamics tests


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| liver fibrosis<br>liver biopsy proved | Diagnostic Test: hemodynamics tests<br>* Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound<br>|
| portal hypertension<br>hepatic venous pressure gradient (HVPG) proved | Diagnostic Test: hemodynamics tests<br>* Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension | baseline | 
| Specificity | Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension | baseline | 
| Positive predictive value (PPV) | Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension | baseline | 
| Negative predictive value (NPV) | Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension | baseline | 
| Area under ROC curve (AUROC) | Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive, Hemodynamics