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

Shanghai Zhongshan Hospital1 site in 1 country200 target enrollmentOctober 9, 2017

ConditionsLiver Fibrosis Cirrhosis Portal Hypertension

Overview

Phase: N/A
Intervention: Not specified
Conditions: Liver Fibrosis
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: Positive predictive value (PPV)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

October 9, 2017

End Date

December 31, 2020

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.