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Clinical Trials/NCT03277651
NCT03277651UnknownNot Applicable

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

Shanghai Zhongshan Hospital1 site in 1 country200 target enrollmentStarted: October 9, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Positive predictive value (PPV)

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Positive predictive value (PPV)

Time Frame: baseline

Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Negative predictive value (NPV)

Time Frame: baseline

Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Specificity

Time Frame: baseline

Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Area under ROC curve (AUROC)

Time Frame: baseline

Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Sensitivity

Time Frame: baseline

Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shanghai Zhongshan Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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