<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/NCT03027921</url>
  </required_header>
  <id_info>
    <org_study_id>49RC16_0164</org_study_id>
    <nct_id>NCT03027921</nct_id>
  </id_info>
  <brief_title>Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis</brief_title>
  <acronym>DECHO2</acronym>
  <official_title>Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <brief_summary>
    <textblock>
      The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic&#xD;
      liver diseases. The early detection of fibrosis is important for determining disease&#xD;
      progression and postponing the evolution of chronic hepatitis into cirrhosis via the&#xD;
      implementation of prompt and specific treatment. However, as chronic liver disease can remain&#xD;
      asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when&#xD;
      life-threatening complications start appearing.&#xD;
&#xD;
      Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In&#xD;
      this setting, blood fibrosis tests and transient elastography have been shown to be accurate,&#xD;
      and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic&#xD;
      liver diseases. However, these tests are usually performed by a hepatologist to whom the&#xD;
      patient has been referred following the appearance of symptoms suggestive of chronic liver&#xD;
      disease. Thus the number of patient diagnosed early by these new tools, that is in the period&#xD;
      before symptoms start appearing and during which preventative measures may be particularly&#xD;
      beneficial, remains quite low in relation to the prevalence of the disease. This prevalence&#xD;
      has been estimated to 0.5 to 2.8 % in general population.&#xD;
&#xD;
      Many studies have identified the value of hemodynamic and morphological ultrasound parameter&#xD;
      in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely&#xD;
      used for various symptoms, and thus could be an excellent way to detect patients with signs&#xD;
      evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for&#xD;
      confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be&#xD;
      feasible during a nonspecific US examination, and by any radiologist, these signs should be&#xD;
      easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase&#xD;
      the screening interest of ultrasound examination.&#xD;
&#xD;
      The main aim of the present study was thus to validate 3 simple US signs in patients referred&#xD;
      for ultrasound abdominal examination for reasons other than suspicion of liver disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the number of patients with severe hepatic fibrosis detected by a progressive algorithm combining simple ultrasound signs of fibrosis and measurement of liver hardness in a non-suspect population of chronic hepatopathies.</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cirrhosis</condition>
  <arm_group>
    <arm_group_label>hepatic ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all patients will have hepatic ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>elastography</intervention_name>
    <arm_group_label>hepatic ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to an ultrasound unit for abdominal US examination, whatever the&#xD;
             indication.&#xD;
&#xD;
          -  Patient with Social Security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Previously identified chronic liver disease&#xD;
&#xD;
          -  Hematological disease&#xD;
&#xD;
          -  Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Victoire Cartier, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03027921
org study id: 49RC16_0164
nct id: NCT03027921
lead sponsor: 
The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic
      liver diseases. The early detection of fibrosis is important for determining disease
      progression and postponing the evolution of chronic hepatitis into cirrhosis via the
      implementation of prompt and specific treatment. However, as chronic liver disease can remain
      asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when
      life-threatening complications start appearing.

      Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In
      this setting, blood fibrosis tests and transient elastography have been shown to be accurate,
      and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic
      liver diseases. However, these tests are usually performed by a hepatologist to whom the
      patient has been referred following the appearance of symptoms suggestive of chronic liver
      disease. Thus the number of patient diagnosed early by these new tools, that is in the period
      before symptoms start appearing and during which preventative measures may be particularly
      beneficial, remains quite low in relation to the prevalence of the disease. This prevalence
      has been estimated to 0.5 to 2.8 % in general population.

      Many studies have identified the value of hemodynamic and morphological ultrasound parameter
      in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely
      used for various symptoms, and thus could be an excellent way to detect patients with signs
      evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for
      confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be
      feasible during a nonspecific US examination, and by any radiologist, these signs should be
      easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase
      the screening interest of ultrasound examination.

      The main aim of the present study was thus to validate 3 simple US signs in patients referred
      for ultrasound abdominal examination for reasons other than suspicion of liver disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Evaluate the number of patients with severe hepatic fibrosis detected by a progressive algorithm combining simple ultrasound signs of fibrosis and measurement of liver hardness in a non-suspect population of chronic hepatopathies.
time frame: 6 month
arm group label: hepatic ultrasound
arm group type: Experimental
description: all patients will have hepatic ultrasound
intervention type: Other
intervention name: elastography
arm group label: hepatic ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Liver Cirrhosis