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A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity

Primary Purpose

Cirrhosis, Liver Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound viscoelasticity
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The department of Ultrasound, the third affiliated hospital of Sun Yat-son UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

training cohort

testing cohort

Arm Description

ultrasound viscoelasticity

ultrasound viscoelasticity

Outcomes

Primary Outcome Measures

liver fibrosis stage
the degree of liver fibrosis according to metavir scores.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
September 1, 2021
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03777293
Brief Title
A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity
Official Title
Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
training cohort
Arm Type
Experimental
Arm Description
ultrasound viscoelasticity
Arm Title
testing cohort
Arm Type
Other
Arm Description
ultrasound viscoelasticity
Intervention Type
Device
Intervention Name(s)
ultrasound viscoelasticity
Other Intervention Name(s)
LOGIQ E produced by GE, Aplio i900 produced by Canon
Intervention Description
use these devices to do ultrasound examination in chronic liver disease patients
Primary Outcome Measure Information:
Title
liver fibrosis stage
Description
the degree of liver fibrosis according to metavir scores.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Lu, PHD
Phone
13560357934
Email
luxue2@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Rongqin, phd
Phone
020-85252374
Email
zhengrq@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Rongqin, phd
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongqin RQ Zheng, doctor
Phone
0086-02085252010
Email
zssyzrq@163.com
First Name & Middle Initial & Last Name & Degree
Xue X Lu, doctor
Phone
0086-02085252374
Email
luxue2@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Rongqin RQ Zheng, doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35916675
Citation
Zhang XQ, Zheng RQ, Jin JY, Wang JF, Zhang T, Zeng J. US Shear-Wave Elastography Dispersion for Characterization of Chronic Liver Disease. Radiology. 2022 Dec;305(3):597-605. doi: 10.1148/radiol.212609. Epub 2022 Aug 2.
Results Reference
derived

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A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity

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