Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

• Conditions: Liver Fibrosis; Cirrhosis; Portal Hypertension
• Interventions: Diagnostic Test: hemodynamics tests

• Registration Number: NCT03277651
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-10-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver fibrosis	hemodynamics tests	liver biopsy proved
portal hypertension	hemodynamics tests	hepatic venous pressure gradient (HVPG) proved

Primary Outcome Measures

Name	Time	Method
Positive predictive value (PPV)	baseline	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Negative predictive value (NPV)	baseline	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Specificity	baseline	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Area under ROC curve (AUROC)	baseline	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Sensitivity	baseline	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Trial Locations

Locations (1)

Zhongshan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China