<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/NCT02184000</url>
  </required_header>
  <id_info>
    <org_study_id>Real-Time Elasto</org_study_id>
    <nct_id>NCT02184000</nct_id>
  </id_info>
  <brief_title>The Role of Strain Elastography in Staging Liver Fibrosis</brief_title>
  <acronym>SELF</acronym>
  <official_title>Usefulness of the Strain Elastography in the Assessment of Liver Fibrosis in Chronic Hepatopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Medicine and Pharmacy Craiova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Medicine and Pharmacy &quot;Victor Babes&quot; Timisoara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Medicine and Pharmacy Craiova</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in&#xD;
      chronic hepatopathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      Establishing liver fibrosis grade in patients with chronic viral hepatitis is very important&#xD;
      for the prognostic assessment and in making the decision to initiate antiviral treatment.&#xD;
      Although the liver biopsy remains the gold standard, recent studies focused on establishing&#xD;
      the role of noninvasive methods in liver fibrosis grading.&#xD;
&#xD;
      Elastography is an imaging method which estimates tissue elasticity. The first elastography&#xD;
      method which appeared was Transient Elastography (TE), followed by Real Time Elastography&#xD;
      (RT-E) and Acoustic Radiation Force Impulse (ARFI). TE was a method especially developed for&#xD;
      noninvasive assessment of liver fibrosis as an alternative to liver biopsy. Unlike these,&#xD;
      RT-E and ARFI have multiple applications in diffuse and tumoral pathology.&#xD;
&#xD;
      Transient Elastography (FibroScan) represents a noninvasive method useful in detecting the&#xD;
      degree of liver fibrosis. The ultrasound transducer probe is able to generate elastic shear&#xD;
      waves that propagate through the liver tissue as well as to measure their speed in the&#xD;
      tissue. Wave speed is directly related to tissue stiffness which is expressed in kilopascals&#xD;
      [1]. Initially, this method was validated for use and considered for chronic hepatitis&#xD;
      management guidelines, then for human immunodeficiency virus/hepatitis C virus (HCV)&#xD;
      co-infection and cholestatic liver diseases. FibroScan failures to give reliable results in&#xD;
      obese patients were reduced by developing a new XL probe which facilitated an alternative&#xD;
      noninvasive method to liver biopsy for liver fibrosis assessment [2].&#xD;
&#xD;
      Acoustic Radiation Force Impulse (ARFI) was proposed as an alternative to FibroScan for the&#xD;
      assessment of liver tissue elasticity, using a conventional ultrasound machine. The main&#xD;
      advantages of this method are the possibility of producing real-time images and its&#xD;
      feasibility in patients with ascites. Preliminary studies show better results for predicting&#xD;
      advanced grades of liver fibrosis than for mild to moderate fibrosis where the method is less&#xD;
      sensitive [3].&#xD;
&#xD;
      Real Time Elastography (RT-E) estimates relative tissue stiffness based on soft tissue&#xD;
      distortion and data are provided as real time color images [4, 5]. This is a real time method&#xD;
      that could also be used for patients with ascites. The method is not validated for liver&#xD;
      fibrosis assessment as there are few studies published so far. The appearance of the&#xD;
      elastography software on the convex probe with high penetration and possibility for&#xD;
      elastography to visualize the liver entirely and the development of information elastography&#xD;
      measurement information programs open new perspectives in noninvasive assessment of liver&#xD;
      pathology by RT-E. There are two recent studies showing good results of the software for&#xD;
      quantitative analysis in RT-E equipment.&#xD;
&#xD;
      The aim of this study is to establish the role of elastographic methods (ARFI and RT-E) in&#xD;
      liver fibrosis assessment in patients with chronic viral hepatitis. This multicentric&#xD;
      prospective trial will be approved by the ethical committee of each centre.&#xD;
&#xD;
      AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in&#xD;
      noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis.&#xD;
&#xD;
      MATERIAL AND METHODS&#xD;
&#xD;
      All patients are enrolled consecutively. Patient data are collected (name initials, age, sex,&#xD;
      Civil Registration Number), liver disease etiology, anthropometric data (body mass index).&#xD;
&#xD;
      The following blood parameters are included: aspartate aminotransferase (AST), alanine&#xD;
      aminotransferase (ALT), γ -glutamyl transpeptidase, γ globulins, platelet count The following&#xD;
      indices are calculated: AST/ALT; AST-to-platelet ratio index (APRI); AST/upper limit of&#xD;
      normal 100/platelet count (104 /mm3 ) , and FibroIndex [1.738 0.064 x platelet count (104&#xD;
      /mm3 ) + 0.005 x AST (U/l) + 0.463 x γ -globulin (g/dl)] Transient elastography is performed&#xD;
      using FibroScan (FibroScan, Echosens) with the patient lying in the dorsal decubitus position&#xD;
      and with his right arm in maximum abduction. The tip of the transducer probe is placed in the&#xD;
      median axillary line in the intercostal space corresponding to the right lobe of the liver.&#xD;
      The pressure index on the screen indicates that the pressure applied with the probe is&#xD;
      compatible with the measurement. Ten measurements per examination are necessary for good&#xD;
      accuracy of the stiffness assessment, considering the final result expressed in kilopascals&#xD;
      as the mean of the ten measurements. M and XL probes for obese patients are used.&#xD;
&#xD;
      Hitachi Real Time Ultrasound Elastography is performed using the 5-1 MHz (EUP-L52) linear&#xD;
      transducer from Hitachi Preirus equipment (Hitachi Aloka Medical Tokyo, Japan). But, in order&#xD;
      to accommodate the pacient and to get a good section of liver, initialy, we performe&#xD;
      ultrasound exam with the convex transducer. Dual imaging is set in such a manner as to be&#xD;
      visible on the screen in a 2D image as well as in an elastographic image juxtaposed over the&#xD;
      2D image. The examination is underwent through right lobe, V-VIII intercostaly spaces,&#xD;
      between the anterior and middle axillary line, with the transducer towards the direction of&#xD;
      heart. The examination is performed while the pacient is holding its breath with constant&#xD;
      compression on the probe to avoid liver moving in a lateral direction due to heart movement.&#xD;
      The interest region (ROI) is inside the liver parenchyma, 1 cm under the liver capsule, in a&#xD;
      selected box of 1/2,5 cm. The aria of interest is chosen so that the 2D image is as clear as&#xD;
      possible, the large vessels avoided and the artifacts given by ribs and lungs. For each&#xD;
      patient is recording 3 different clips, that includes a stable elastography image of at least&#xD;
      5 heart beats. A sequence on the negative pick is selected, and a value for each film is&#xD;
      calculating. Everything is saved in the report and in data base, along with the 11 parameters&#xD;
      given by the Strain Histogram measurement software such as: mean relative strain value&#xD;
      (MEAN); standard deviation of relative strain value (SD); percentage of low strain area&#xD;
      (percentage of blue color area - %AREA); complexity of low strain area (calculated as&#xD;
      perimeter 2 /area - COMP); skewness (SKEW); kurtosis (KURT); contrast (CONT); entropy (ENT);&#xD;
      textural complexity, inverse difference moment (IDM); angular second moment (ASM);&#xD;
      Correlation (CORR) indicates the feature value of the texture directivity.&#xD;
&#xD;
      ARFI- Acoustic Radiation Force Impulse Technology [ACUSON S2000]. Scanning is performed with&#xD;
      a right intercostal approach, in the right liver lobe, segment V-VIII, 1-2 cm under the liver&#xD;
      capsule, with minimal scanning pressure applied by the operator, while the patients is asks&#xD;
      to stop normal breathing for a moment, in order to minimize breathing motion. The operator&#xD;
      selects the depth at which the liver elasticity is evaluated by placing a &quot;measuring box&quot; (10&#xD;
      mm long, 5 mm wide) in the desired area. The maximum depth at which ARFI measurements can be&#xD;
      performed is 8 cm. A total of 10 valid measurements performe in every patient and a median&#xD;
      value in m/s is calculate.&#xD;
&#xD;
      Liver biopsy samples is takes via a right intercostal space from the right liver lobe with&#xD;
      direct sonographic guidance. Liver fibrosis stages is evaluate semiquantitatively according&#xD;
      to the METAVIR scoring system on an F0-F4 scale&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      The diagnostic performance of ARFI and RT-E for liver fibrosis will determine in terms of&#xD;
      sensitivity, specificity, positive predictive value, negative predictive value, diagnostic&#xD;
      accuracy and area under the receiver operating characteristic curve (AUROC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Strain Elastography results</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Usefulness of strain elastography recordings for the evaluation of liver fibrosis</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Chronic Liver Disease</condition>
  <arm_group>
    <arm_group_label>1. the control group healthy adult volunteers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>2. patients with chronic hepatitis B or C</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>3. pacients with liver cirrhosis type B or C</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in the study will be healthy voluntaries, patients with chronic&#xD;
        hepatitis B or C and patients with liver cirrhosis. ARFI and Hitachi elastography will be&#xD;
        performed for each patient and the results will be compared with final diagnosis. The final&#xD;
        diagnosis (the stage) will be established based on Transient elastography and or liver&#xD;
        biopsy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years old&#xD;
&#xD;
          -  Study will include three groups of patients as follows:&#xD;
&#xD;
               1. Group I: patients with chronic hepatitis B or C (defined by the presence of serum&#xD;
                  anti HCV antibody or serum hepatitis B surface antibody)&#xD;
&#xD;
               2. Group II (the control group): healthy adult volunteers&#xD;
&#xD;
               3. Group III: patients with hepatic cirrhosis type B or C&#xD;
&#xD;
          -  There at least one reference method available for patients with chronic hepatitis&#xD;
             (Transient elastography/ liver biopsy)&#xD;
&#xD;
          -  Hepatic cirrhosis diagnosis is established using clinical and paraclinical features&#xD;
             (ultrasonography, superior digestive endoscopy)&#xD;
&#xD;
          -  A written informed consent is given to each patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindication for elastography (pregnant women or who are&#xD;
             breastfeeding) and patients with pacemakers&#xD;
&#xD;
          -  Patients with liver disease of other etiology than viral infection (autoimmune&#xD;
             hepatitis, primary biliary hepatitis, primary sclerosing cholangitis, hemochromatosis,&#xD;
             alfa 1-antitrypsin deficiency, or Wilson's disease)&#xD;
&#xD;
          -  History of alcohol abuse (alcohol intake&gt; 20g/day)&#xD;
&#xD;
          -  Patients under treatment with hepatotoxic drugs (methotrexate, amiodarone,&#xD;
             corticotherapy , chemotherapy, hormonotherapy)&#xD;
&#xD;
          -  Patients with technically unfeasible TE: patients with ascites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Saftoiu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMF Craiova</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Larisa SANDULESCU, MD, PhD</last_name>
    <phone>+40723968354</phone>
    <email>larisasandulescu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Researche Center of Gastroenterology and Hepatology</name>
      <address>
        <city>Craiova</city>
        <state>Dolj</state>
        <zip>200635</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Larisa Sandulescu, MD, PhD</last_name>
      <phone>40723968354</phone>
      <email>arisasandulescu@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Adrian Saftoiu, Saftoiu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Medicine and Pharmacy</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>200635</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alina Popescu, Md, PhD</last_name>
      <email>alinamirceapopescu@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Ioan Sporea, Md, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <citation>Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.</citation>
    <PMID>18334275</PMID>
  </reference>
  <reference>
    <citation>de Ledinghen V, Vergniol J, Foucher J, El-Hajbi F, Merrouche W, Rigalleau V. Feasibility of liver transient elastography with FibroScan using a new probe for obese patients. Liver Int. 2010 Aug;30(7):1043-8. doi: 10.1111/j.1478-3231.2010.02258.x. Epub 2010 May 14.</citation>
    <PMID>20492500</PMID>
  </reference>
  <reference>
    <citation>Friedrich-Rust M, Nierhoff J, Lupsor M, Sporea I, Fierbinteanu-Braticevici C, Strobel D, Takahashi H, Yoneda M, Suda T, Zeuzem S, Herrmann E. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. 2012 Feb;19(2):e212-9. doi: 10.1111/j.1365-2893.2011.01537.x. Epub 2011 Oct 30.</citation>
    <PMID>22239521</PMID>
  </reference>
  <reference>
    <citation>Koizumi Y, Hirooka M, Kisaka Y, Konishi I, Abe M, Murakami H, Matsuura B, Hiasa Y, Onji M. Liver fibrosis in patients with chronic hepatitis C: noninvasive diagnosis by means of real-time tissue elastography--establishment of the method for measurement. Radiology. 2011 Feb;258(2):610-7. doi: 10.1148/radiol.10100319.</citation>
    <PMID>21273523</PMID>
  </reference>
  <reference>
    <citation>Gheonea DI, Saftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Sandulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6. doi: 10.3748/wjg.v16.i14.1720.</citation>
    <PMID>20380003</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Medicine and Pharmacy Craiova</investigator_affiliation>
    <investigator_full_name>Dan Gheonea</investigator_full_name>
    <investigator_title>MD, PhD, MSc Specialist in Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>strain elastography</keyword>
  <keyword>hepatopathy</keyword>
  <keyword>liver fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT02184000
org study id: Real-Time Elasto
nct id: NCT02184000
lead sponsor: 
collaborator: 
has dmc: Yes
AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in
      chronic hepatopathy
INTRODUCTION

      Establishing liver fibrosis grade in patients with chronic viral hepatitis is very important
      for the prognostic assessment and in making the decision to initiate antiviral treatment.
      Although the liver biopsy remains the gold standard, recent studies focused on establishing
      the role of noninvasive methods in liver fibrosis grading.

      Elastography is an imaging method which estimates tissue elasticity. The first elastography
      method which appeared was Transient Elastography (TE), followed by Real Time Elastography
      (RT-E) and Acoustic Radiation Force Impulse (ARFI). TE was a method especially developed for
      noninvasive assessment of liver fibrosis as an alternative to liver biopsy. Unlike these,
      RT-E and ARFI have multiple applications in diffuse and tumoral pathology.

      Transient Elastography (FibroScan) represents a noninvasive method useful in detecting the
      degree of liver fibrosis. The ultrasound transducer probe is able to generate elastic shear
      waves that propagate through the liver tissue as well as to measure their speed in the
      tissue. Wave speed is directly related to tissue stiffness which is expressed in kilopascals
      [1]. Initially, this method was validated for use and considered for chronic hepatitis
      management guidelines, then for human immunodeficiency virus/hepatitis C virus (HCV)
      co-infection and cholestatic liver diseases. FibroScan failures to give reliable results in
      obese patients were reduced by developing a new XL probe which facilitated an alternative
      noninvasive method to liver biopsy for liver fibrosis assessment [2].

      Acoustic Radiation Force Impulse (ARFI) was proposed as an alternative to FibroScan for the
      assessment of liver tissue elasticity, using a conventional ultrasound machine. The main
      advantages of this method are the possibility of producing real-time images and its
      feasibility in patients with ascites. Preliminary studies show better results for predicting
      advanced grades of liver fibrosis than for mild to moderate fibrosis where the method is less
      sensitive [3].

      Real Time Elastography (RT-E) estimates relative tissue stiffness based on soft tissue
      distortion and data are provided as real time color images [4, 5]. This is a real time method
      that could also be used for patients with ascites. The method is not validated for liver
      fibrosis assessment as there are few studies published so far. The appearance of the
      elastography software on the convex probe with high penetration and possibility for
      elastography to visualize the liver entirely and the development of information elastography
      measurement information programs open new perspectives in noninvasive assessment of liver
      pathology by RT-E. There are two recent studies showing good results of the software for
      quantitative analysis in RT-E equipment.

      The aim of this study is to establish the role of elastographic methods (ARFI and RT-E) in
      liver fibrosis assessment in patients with chronic viral hepatitis. This multicentric
      prospective trial will be approved by the ethical committee of each centre.

      AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in
      noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis.

      MATERIAL AND METHODS

      All patients are enrolled consecutively. Patient data are collected (name initials, age, sex,
      Civil Registration Number), liver disease etiology, anthropometric data (body mass index).

      The following blood parameters are included: aspartate aminotransferase (AST), alanine
      aminotransferase (ALT), γ -glutamyl transpeptidase, γ globulins, platelet count The following
      indices are calculated: AST/ALT; AST-to-platelet ratio index (APRI); AST/upper limit of
      normal 100/platelet count (104 /mm3 ) , and FibroIndex [1.738 0.064 x platelet count (104
      /mm3 ) + 0.005 x AST (U/l) + 0.463 x γ -globulin (g/dl)] Transient elastography is performed
      using FibroScan (FibroScan, Echosens) with the patient lying in the dorsal decubitus position
      and with his right arm in maximum abduction. The tip of the transducer probe is placed in the
      median axillary line in the intercostal space corresponding to the right lobe of the liver.
      The pressure index on the screen indicates that the pressure applied with the probe is
      compatible with the measurement. Ten measurements per examination are necessary for good
      accuracy of the stiffness assessment, considering the final result expressed in kilopascals
      as the mean of the ten measurements. M and XL probes for obese patients are used.

      Hitachi Real Time Ultrasound Elastography is performed using the 5-1 MHz (EUP-L52) linear
      transducer from Hitachi Preirus equipment (Hitachi Aloka Medical Tokyo, Japan). But, in order
      to accommodate the pacient and to get a good section of liver, initialy, we performe
      ultrasound exam with the convex transducer. Dual imaging is set in such a manner as to be
      visible on the screen in a 2D image as well as in an elastographic image juxtaposed over the
      2D image. The examination is underwent through right lobe, V-VIII intercostaly spaces,
      between the anterior and middle axillary line, with the transducer towards the direction of
      heart. The examination is performed while the pacient is holding its breath with constant
      compression on the probe to avoid liver moving in a lateral direction due to heart movement.
      The interest region (ROI) is inside the liver parenchyma, 1 cm under the liver capsule, in a
      selected box of 1/2,5 cm. The aria of interest is chosen so that the 2D image is as clear as
      possible, the large vessels avoided and the artifacts given by ribs and lungs. For each
      patient is recording 3 different clips, that includes a stable elastography image of at least
      5 heart beats. A sequence on the negative pick is selected, and a value for each film is
      calculating. Everything is saved in the report and in data base, along with the 11 parameters
      given by the Strain Histogram measurement software such as: mean relative strain value
      (MEAN); standard deviation of relative strain value (SD); percentage of low strain area
      (percentage of blue color area - %AREA); complexity of low strain area (calculated as
      perimeter 2 /area - COMP); skewness (SKEW); kurtosis (KURT); contrast (CONT); entropy (ENT);
      textural complexity, inverse difference moment (IDM); angular second moment (ASM);
      Correlation (CORR) indicates the feature value of the texture directivity.

      ARFI- Acoustic Radiation Force Impulse Technology [ACUSON S2000]. Scanning is performed with
      a right intercostal approach, in the right liver lobe, segment V-VIII, 1-2 cm under the liver
      capsule, with minimal scanning pressure applied by the operator, while the patients is asks
      to stop normal breathing for a moment, in order to minimize breathing motion. The operator
      selects the depth at which the liver elasticity is evaluated by placing a "measuring box" (10
      mm long, 5 mm wide) in the desired area. The maximum depth at which ARFI measurements can be
      performed is 8 cm. A total of 10 valid measurements performe in every patient and a median
      value in m/s is calculate.

      Liver biopsy samples is takes via a right intercostal space from the right liver lobe with
      direct sonographic guidance. Liver fibrosis stages is evaluate semiquantitatively according
      to the METAVIR scoring system on an F0-F4 scale

      Statistical analysis

      The diagnostic performance of ARFI and RT-E for liver fibrosis will determine in terms of
      sensitivity, specificity, positive predictive value, negative predictive value, diagnostic
      accuracy and area under the receiver operating characteristic curve (AUROC).
observational model: Case-Only
time perspective: Prospective
measure: Strain Elastography results
time frame: up to 24 weeks
description: Usefulness of strain elastography recordings for the evaluation of liver fibrosis
arm group label: 1. the control group healthy adult volunteers
arm group label: 2. patients with chronic hepatitis B or C
arm group label: 3. pacients with liver cirrhosis type B or C
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian Saftoiu, MD, PhD
role: Principal Investigator
affiliation: UMF Craiova
last name: Larisa SANDULESCU, MD, PhD
phone: +40723968354
email: larisasandulescu@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Romania
citation: Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
PMID: 18334275
citation: de Ledinghen V, Vergniol J, Foucher J, El-Hajbi F, Merrouche W, Rigalleau V. Feasibility of liver transient elastography with FibroScan using a new probe for obese patients. Liver Int. 2010 Aug;30(7):1043-8. doi: 10.1111/j.1478-3231.2010.02258.x. Epub 2010 May 14.
PMID: 20492500
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citation: Gheonea DI, Saftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Sandulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6. doi: 10.3748/wjg.v16.i14.1720.
PMID: 20380003
responsible party type: Principal Investigator
investigator affiliation: University of Medicine and Pharmacy Craiova
investigator full name: Dan Gheonea
investigator title: MD, PhD, MSc Specialist in Gastroenterology
mesh term: Liver Diseases
mesh term: Liver Cirrhosis
mesh term: Fibrosis