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
About this trial
This is an interventional diagnostic trial for Cirrhosis
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.
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
NCT ID
NCT03777293
First Posted
December 11, 2018
Last Updated
September 1, 2021
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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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