Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

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

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

Study Overview

• Status: Unknown
• Conditions: Cirrhosis; Portal Hypertension; Liver Fibrosis
• Intervention / Treatment: Diagnostic test: hemodynamics tests

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University
      • Contact: Shengdi Wu, M.D.; Email: wu.shengdi@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan hospital Fudan University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
liver fibrosis; liver biopsy proved	Diagnostic test: hemodynamics tests; Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound
portal hypertension; hepatic venous pressure gradient (HVPG) proved	Diagnostic test: hemodynamics tests; Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Wei Jiang, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Hemodynamics; noninvasive
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Fibrosis; Hypertension; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: Hemodynamics Models for CLD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No