<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777293</url>
  </required_header>
  <id_info>
    <org_study_id>sysu2018</org_study_id>
    <nct_id>NCT03777293</nct_id>
  </id_info>
  <brief_title>A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity</brief_title>
  <official_title>Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The accuracy of ultrasound elastography for assessing liver fibrosis by measuring liver&#xD;
      stiffness (elastic modulus) is better than traditional method. Elastography has certain&#xD;
      advantage such as non-invasive, simple, real-time and it has been recommended by clinical&#xD;
      guidelines.&#xD;
&#xD;
      However, some chanllenging scientific problems showed up with further research and clinical&#xD;
      practice. Firstly, present elastography machines can only calculate liver stiffness from&#xD;
      shear wave speed or elastic modulus but ignore other physical characteristics such as tissue&#xD;
      viscosity. So far, present technique simply assume liver as an idealized model with isotropic&#xD;
      elasticity to assess liver fibrosis while liver is actually anisotropic and viscoelastic.&#xD;
      What's more, theoretically, there are not only different solid state structures such as cell&#xD;
      organization and vessel but also flowing liquid such as blood and bile. Thus, ignoring&#xD;
      viscosity and evaluating elasticity only is unreasonable. In the other hand, a number of&#xD;
      confounding factors have been found to influence liver stiffness measurement by elastography.&#xD;
      Different pathological chang of liver including inflammation, necrosis, cholestasis and&#xD;
      inhomogeneity among the individuals such as obesity, ascites, et,al. will decrease the&#xD;
      accuracy of liver stiffness measurement and liver fibrosis staging by elastography.&#xD;
&#xD;
      In fact, liver fibrosis is a dynamic process. Liver fibrosis is a reaction of compensation&#xD;
      and repair for inflammation and necrosis as well as a contributing factor for liver damage.&#xD;
      This dynamic process constitutes the common characteristic of chronic liver disease and&#xD;
      result in the complicated biological mechanical characteristics of liver. In consequence, how&#xD;
      to measure liver viscosity and elasticity respectively, and to evaluate liver fibrosis stage&#xD;
      and Inflammation degree accurately during the complicated and dynamic pathological process is&#xD;
      the key scientific problem demanding solution, which is also the urgent requirement of&#xD;
      related fundamental research and clinical practice.&#xD;
&#xD;
      Therefore, this project plan to apply LOGIQ E viscoelastography machine as research tool, rat&#xD;
      liver fibrosis model and rat liver failure model as research object to investigate the&#xD;
      correlation between liver viscoelastography measurement and liver fibrosis stage and&#xD;
      Inflammation degree. The investigators also aim to assess the feasibility of using&#xD;
      ulstrasound viscoelastography to evaluate liver fibrosis stage and Inflammation degree&#xD;
      dynamically.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>liver fibrosis stage</measure>
    <time_frame>1 year</time_frame>
    <description>the degree of liver fibrosis according to metavir scores.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>training cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ultrasound viscoelasticity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>testing cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ultrasound viscoelasticity</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound viscoelasticity</intervention_name>
    <description>use these devices to do ultrasound examination in chronic liver disease patients</description>
    <arm_group_label>testing cohort</arm_group_label>
    <arm_group_label>training cohort</arm_group_label>
    <other_name>LOGIQ E produced by GE</other_name>
    <other_name>Aplio i900 produced by Canon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agree to have liver biopsy in later therapy&#xD;
&#xD;
          -  agree to participate in our study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic malignant mass lesion&#xD;
&#xD;
          -  After liver transplantation&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Liver biopsy specimens do not meet the requirements: speciments length &lt;15mm, or&#xD;
             numbers of the portal ducts &lt;6.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zheng Rongqin, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xue Lu, PHD</last_name>
    <phone>13560357934</phone>
    <email>luxue2@mail2.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zheng Rongqin, phd</last_name>
    <phone>020-85252374</phone>
    <email>zhengrq@mail.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The department of Ultrasound, the third affiliated hospital of Sun Yat-son University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongqin RQ Zheng, doctor</last_name>
      <phone>0086-02085252010</phone>
      <email>zssyzrq@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Xue X Lu, doctor</last_name>
      <phone>0086-02085252374</phone>
      <email>luxue2@mail2.sysu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Rongqin RQ Zheng, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Rongqin Zheng</investigator_full_name>
    <investigator_title>Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777293
org study id: sysu2018
nct id: NCT03777293
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: liver fibrosis stage
time frame: 1 year
description: the degree of liver fibrosis according to metavir scores.
arm group label: training cohort
arm group type: Experimental
description: ultrasound viscoelasticity
arm group label: testing cohort
arm group type: Other
description: ultrasound viscoelasticity
intervention type: Device
intervention name: ultrasound viscoelasticity
description: use these devices to do ultrasound examination in chronic liver disease patients
arm group label: testing cohort
arm group label: training cohort
other name: LOGIQ E produced by GE
other name: Aplio i900 produced by Canon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zheng Rongqin, phd
role: Principal Investigator
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
last name: Xue Lu, PHD
phone: 13560357934
email: luxue2@mail2.sysu.edu.cn
last name: Zheng Rongqin, phd
phone: 020-85252374
email: zhengrq@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Rongqin Zheng
investigator title: Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound
mesh term: Liver Diseases
sharing ipd: Undecided