Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03277651
• Other study ID #: Hemodynamics Models for CLD
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2017
• Last updated: January 9, 2018
• Start date: October 9, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Shengdi Wu
• Phone: 0086-021-64041990
• Email: wu.shengdi[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Liver Fibrosis
• Portal Hypertension

Intervention

Diagnostic Test:
• hemodynamics tests
Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

Locations

Country	Name	City	State
China	Zhongshan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension	baseline
Primary	Specificity	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension	baseline
Primary	Positive predictive value (PPV)	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension	baseline
Primary	Negative predictive value (NPV)	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension	baseline
Primary	Area under ROC curve (AUROC)	Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension	baseline