- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777293
A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity
Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xue Lu, PHD
- Phone Number: 13560357934
- Email: luxue2@mail2.sysu.edu.cn
Study Contact Backup
- Name: Zheng Rongqin, phd
- Phone Number: 020-85252374
- Email: zhengrq@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
-
Contact:
- Rongqin RQ Zheng, doctor
- Phone Number: 0086-02085252010
- Email: zssyzrq@163.com
-
Principal Investigator:
- Rongqin RQ Zheng, doctor
-
Contact:
- Xue X Lu, doctor
- Phone Number: 0086-02085252374
- Email: luxue2@mail2.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: training cohort
ultrasound viscoelasticity
|
use these devices to do ultrasound examination in chronic liver disease patients
Other Names:
|
Other: testing cohort
ultrasound viscoelasticity
|
use these devices to do ultrasound examination in chronic liver disease patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver fibrosis stage
Time Frame: 1 year
|
the degree of liver fibrosis according to metavir scores.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zheng Rongqin, phd, Third Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sysu2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Diseases
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Medical College of WisconsinRecruiting
-
Beijing Friendship HospitalUnknownNonalcoholic Fatty Liver Disease | Liver Steatosis | Liver FibrosisChina
-
Shiraz University of Medical SciencesCompletedFatty Liver | Fatty Liver, NonalcoholicIran, Islamic Republic of
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Johannes Gutenberg University MainzUniversity of JenaCompletedNon-alcoholic Fatty Liver Disease | Fatty Liver, NonalcoholicGermany
-
The Cleveland ClinicCompleted
-
Hadassah Medical OrganizationUnknown
Clinical Trials on ultrasound viscoelasticity
-
Ahram Canadian UniversityRecruitingCarpal Tunnel Syndrome | Median Neuropathy, Carpal TunnelEgypt
-
Eskisehir Osmangazi UniversityCompletedCarpal Tunnel Syndrome
-
Cairo UniversityUnknown
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingBreast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingShoulder Impingement Syndrome | Shoulder Pain
-
John PelleritoGeneral ElectricActive, not recruiting
-
Samuel Lunenfeld Research Institute, Mount Sinai...CompletedPregnancy | Respiratory Aspiration of Gastric ContentCanada
-
Oregon Health and Science UniversityRecruiting