A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-01-01

Brief Summary

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The accuracy of ultrasound elastography for assessing liver fibrosis by measuring liver stiffness (elastic modulus) is better than traditional method. Elastography has certain advantage such as non-invasive, simple, real-time and it has been recommended by clinical guidelines.

However, some chanllenging scientific problems showed up with further research and clinical practice. Firstly, present elastography machines can only calculate liver stiffness from shear wave speed or elastic modulus but ignore other physical characteristics such as tissue viscosity. So far, present technique simply assume liver as an idealized model with isotropic elasticity to assess liver fibrosis while liver is actually anisotropic and viscoelastic. What's more, theoretically, there are not only different solid state structures such as cell organization and vessel but also flowing liquid such as blood and bile. Thus, ignoring viscosity and evaluating elasticity only is unreasonable. In the other hand, a number of confounding factors have been found to influence liver stiffness measurement by elastography. Different pathological chang of liver including inflammation, necrosis, cholestasis and inhomogeneity among the individuals such as obesity, ascites, et,al. will decrease the accuracy of liver stiffness measurement and liver fibrosis staging by elastography.

In fact, liver fibrosis is a dynamic process. Liver fibrosis is a reaction of compensation and repair for inflammation and necrosis as well as a contributing factor for liver damage. This dynamic process constitutes the common characteristic of chronic liver disease and result in the complicated biological mechanical characteristics of liver. In consequence, how to measure liver viscosity and elasticity respectively, and to evaluate liver fibrosis stage and Inflammation degree accurately during the complicated and dynamic pathological process is the key scientific problem demanding solution, which is also the urgent requirement of related fundamental research and clinical practice.

Therefore, this project plan to apply LOGIQ E viscoelastography machine as research tool, rat liver fibrosis model and rat liver failure model as research object to investigate the correlation between liver viscoelastography measurement and liver fibrosis stage and Inflammation degree. The investigators also aim to assess the feasibility of using ulstrasound viscoelastography to evaluate liver fibrosis stage and Inflammation degree dynamically.

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Detailed Description

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Conditions

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Cirrhosis Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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training cohort

ultrasound viscoelasticity

Group Type EXPERIMENTAL

ultrasound viscoelasticity

Intervention Type DEVICE

use these devices to do ultrasound examination in chronic liver disease patients

testing cohort

ultrasound viscoelasticity

Group Type OTHER

ultrasound viscoelasticity

Intervention Type DEVICE

use these devices to do ultrasound examination in chronic liver disease patients

Interventions

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ultrasound viscoelasticity

use these devices to do ultrasound examination in chronic liver disease patients

Intervention Type DEVICE

Other Intervention Names

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LOGIQ E produced by GE Aplio i900 produced by Canon

Eligibility Criteria

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Inclusion Criteria

* agree to have liver biopsy in later therapy
* agree to participate in our study

Exclusion Criteria

* Hepatic malignant mass lesion
* After liver transplantation
* Pregnant patients
* Liver biopsy specimens do not meet the requirements: speciments length \<15mm, or numbers of the portal ducts \<6.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No