Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

Fudan University

Status

Unknown

Conditions

Portal Hypertension

Cirrhosis

Liver Fibrosis

Treatments

Diagnostic Test: hemodynamics tests

Study type

Observational

Funder types

Other

Identifiers

NCT03277651

Hemodynamics Models for CLD

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.