<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/NCT02208518</url>
  </required_header>
  <id_info>
    <org_study_id>ELASTOSONO-EUS1</org_study_id>
    <nct_id>NCT02208518</nct_id>
  </id_info>
  <brief_title>Quantitative And Qualitative Eus Elastography</brief_title>
  <official_title>Could Quantitative And Qualitative EUS-Elastography Results Be Affected By The Compression Rate And The Diameter Of The Region Of Interest (ROI)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Ecuatoriano de Enfermedades Digestivas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Ecuatoriano de Enfermedades Digestivas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and&#xD;
      staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of&#xD;
      solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine&#xD;
      needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been&#xD;
      introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses,&#xD;
      being an index of tissue elasticity, which may be related to histopathology features (hard&#xD;
      tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However,&#xD;
      recently publications show different results using elastography. Moreover, a lack of data in&#xD;
      Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the&#xD;
      diameter of the region of interest under analysis in previously studies that by physics could&#xD;
      affect the tissue elasticity.&#xD;
&#xD;
      Based on the hypothesis that elastography could be affected by compression rate of the probe&#xD;
      and the diameter of the region of interest analyzed the present study aimed to evaluate the&#xD;
      quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results&#xD;
      determined by the compression rate of the probe (measured by the curve of compression in the&#xD;
      second generation of elastography) and the diameter of the region of interest in normal&#xD;
      pancreatic tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      prospective study performed in patients undergoing for upper-endoscopic ultrasound from&#xD;
      October 31-to end of November 2013. Endoscopic ultrasound-elastography was performed using&#xD;
      linear Pentax-EUS and &quot;Hitachi-Avius&quot;. The quantitative-strain ratio and qualitative&#xD;
      endoscopic ultrasound-elastography was measured in the body of the pancreas taking in&#xD;
      consideration the curve of the compression rate of the probe high: +0.4, middle: 0, low: -0.4&#xD;
      in the largest and smaller region of interest diameters. Analysis for qualitative&#xD;
      elastography was obtained by the predominant color of the pancreatic area studied. Pictures&#xD;
      where recorded and quantitative strain ratio data were calculated comparing endoscopic&#xD;
      ultrasound-elastography of pancreatic tissue with soft tissue (normal mucosal layer: red).&#xD;
      Finally, a comparative analysis was performed between the results with the mean normal value&#xD;
      for quantitative strain ratio previously published for normal pancreatic tissue, and between&#xD;
      the different compression rates of the probe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography</measure>
    <time_frame>two months</time_frame>
    <description>The quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography was measured in the normal body of the pancreas taking in consideration the curve of the compression rate probe high: +0.4 , middle: 0: less than +0.4 and more than -0.4 [around baseline=0], and low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative color elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound elastography of pancreatic tissue with soft tissue (normal mucosal layer: red).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Highest compression rate of the probe</measure>
    <time_frame>4 weeks</time_frame>
    <description>the curve of the Highest compression rate of the probe: +0.4 , in the largest and smaller region of interest diameters</description>
  </other_outcome>
  <other_outcome>
    <measure>Middle compression rate of the probe</measure>
    <time_frame>4 weeks</time_frame>
    <description>the curve of the Middle compression rate of the probe: 0: less than +0.4 and more than -0.4 [around baseline=0], in the largest and smaller region of interest diameters.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lower compression rate of the probe</measure>
    <time_frame>4 weeks</time_frame>
    <description>the curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative elastography</measure>
    <time_frame>8 weeks</time_frame>
    <description>Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Normal Pancreatic Tissue</condition>
  <arm_group>
    <arm_group_label>Elastography analysis</arm_group_label>
    <description>Consecutive patients undergoing for upper endoscopy ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopy ultrasound elastography</intervention_name>
    <description>During a endoscopy ultrasound (EUS) procedure, in patients with normal pancreas at EUS, elastography was performed using a software already included in Hitachi-Avius machine, pressing the button and obtaining colors and pressure curve given by the software</description>
    <arm_group_label>Elastography analysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS-elastography</intervention_name>
    <arm_group_label>Elastography analysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic: patients with upper gastrointestinal submucosal tumors for evaluation&#xD;
        by endoscopic ultrasound&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Endoscopic Ultrasound for evaluate submucosal tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 or &gt; 55; pregnancy&#xD;
&#xD;
          -  history of: pancreatic disease&#xD;
&#xD;
          -  choledocolithiasis&#xD;
&#xD;
          -  symptoms of maldigestion&#xD;
&#xD;
          -  alcohol abuse&#xD;
&#xD;
          -  increased serum levels of pancreatic enzymes&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  Endoscopic Ultrasound with signs of chronic pancreatitis (Rosemont classification)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Robles-Medranda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Ecuatoriano de Enfermedades Digestivas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Ecuatoriano de Enfermedades Digestivas</name>
      <address>
        <city>Guayaquil</city>
        <state>Guayas</state>
        <zip>1301266</zip>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ecuador</country>
  </location_countries>
  <results_reference>
    <citation>Iglesias Garcia JJ, Larino Noia J, Alvarez Castro A, Cigarran B, Dominguez Munoz JE. Second-generation endoscopic ultrasound elastography in the differential diagnosis of solid pancreatic masses. Pancreatic cancer vs. inflammatory mass in chronic pancreatitis. Rev Esp Enferm Dig. 2009 Oct;101(10):723-30. doi: 10.4321/s1130-01082009001000009. English, Spanish.</citation>
    <PMID>19899942</PMID>
  </results_reference>
  <results_reference>
    <citation>Iglesias-Garcia J, Larino-Noia J, Abdulkader I, Forteza J, Dominguez-Munoz JE. Quantitative endoscopic ultrasound elastography: an accurate method for the differentiation of solid pancreatic masses. Gastroenterology. 2010 Oct;139(4):1172-80. doi: 10.1053/j.gastro.2010.06.059. Epub 2010 Jun 27.</citation>
    <PMID>20600020</PMID>
  </results_reference>
  <results_reference>
    <citation>Dawwas MF, Taha H, Leeds JS, Nayar MK, Oppong KW. Diagnostic accuracy of quantitative EUS elastography for discriminating malignant from benign solid pancreatic masses: a prospective, single-center study. Gastrointest Endosc. 2012 Nov;76(5):953-61. doi: 10.1016/j.gie.2012.05.034. Epub 2012 Jul 31.</citation>
    <PMID>22854060</PMID>
  </results_reference>
  <results_reference>
    <citation>Giovannini M, Hookey LC, Bories E, Pesenti C, Monges G, Delpero JR. Endoscopic ultrasound elastography: the first step towards virtual biopsy? Preliminary results in 49 patients. Endoscopy. 2006 Apr;38(4):344-8. doi: 10.1055/s-2006-925158. Erratum In: Endoscopy. 2007 Mar;39(3):257.</citation>
    <PMID>16680632</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopic Ultrasound elastography</keyword>
  <keyword>Quantitative elastography</keyword>
  <keyword>Qualitative elastography</keyword>
  <keyword>Endoscopic Ultrasound</keyword>
  <keyword>Elastography</keyword>
  <!-- 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/NCT02208518
org study id: ELASTOSONO-EUS1
nct id: NCT02208518
lead sponsor: 
has dmc: Yes
Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and
      staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of
      solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine
      needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been
      introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses,
      being an index of tissue elasticity, which may be related to histopathology features (hard
      tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However,
      recently publications show different results using elastography. Moreover, a lack of data in
      Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the
      diameter of the region of interest under analysis in previously studies that by physics could
      affect the tissue elasticity.

      Based on the hypothesis that elastography could be affected by compression rate of the probe
      and the diameter of the region of interest analyzed the present study aimed to evaluate the
      quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results
      determined by the compression rate of the probe (measured by the curve of compression in the
      second generation of elastography) and the diameter of the region of interest in normal
      pancreatic tissue.
prospective study performed in patients undergoing for upper-endoscopic ultrasound from
      October 31-to end of November 2013. Endoscopic ultrasound-elastography was performed using
      linear Pentax-EUS and "Hitachi-Avius". The quantitative-strain ratio and qualitative
      endoscopic ultrasound-elastography was measured in the body of the pancreas taking in
      consideration the curve of the compression rate of the probe high: +0.4, middle: 0, low: -0.4
      in the largest and smaller region of interest diameters. Analysis for qualitative
      elastography was obtained by the predominant color of the pancreatic area studied. Pictures
      where recorded and quantitative strain ratio data were calculated comparing endoscopic
      ultrasound-elastography of pancreatic tissue with soft tissue (normal mucosal layer: red).
      Finally, a comparative analysis was performed between the results with the mean normal value
      for quantitative strain ratio previously published for normal pancreatic tissue, and between
      the different compression rates of the probe.
observational model: Case-Only
time perspective: Prospective
measure: Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography
time frame: two months
description: The quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography was measured in the normal body of the pancreas taking in consideration the curve of the compression rate probe high: +0.4 , middle: 0: less than +0.4 and more than -0.4 [around baseline=0], and low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative color elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound elastography of pancreatic tissue with soft tissue (normal mucosal layer: red).
measure: Highest compression rate of the probe
time frame: 4 weeks
description: the curve of the Highest compression rate of the probe: +0.4 , in the largest and smaller region of interest diameters
measure: Middle compression rate of the probe
time frame: 4 weeks
description: the curve of the Middle compression rate of the probe: 0: less than +0.4 and more than -0.4 [around baseline=0], in the largest and smaller region of interest diameters.
measure: Lower compression rate of the probe
time frame: 4 weeks
description: the curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters
measure: Qualitative elastography
time frame: 8 weeks
description: Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied.
arm group label: Elastography analysis
description: Consecutive patients undergoing for upper endoscopy ultrasound
intervention type: Procedure
intervention name: endoscopy ultrasound elastography
description: During a endoscopy ultrasound (EUS) procedure, in patients with normal pancreas at EUS, elastography was performed using a software already included in Hitachi-Avius machine, pressing the button and obtaining colors and pressure curve given by the software
arm group label: Elastography analysis
intervention type: Device
intervention name: EUS-elastography
arm group label: Elastography analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Carlos Robles-Medranda, MD
role: Principal Investigator
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas
facility: 
country: Ecuador
citation: Iglesias Garcia JJ, Larino Noia J, Alvarez Castro A, Cigarran B, Dominguez Munoz JE. Second-generation endoscopic ultrasound elastography in the differential diagnosis of solid pancreatic masses. Pancreatic cancer vs. inflammatory mass in chronic pancreatitis. Rev Esp Enferm Dig. 2009 Oct;101(10):723-30. doi: 10.4321/s1130-01082009001000009. English, Spanish.
PMID: 19899942
citation: Iglesias-Garcia J, Larino-Noia J, Abdulkader I, Forteza J, Dominguez-Munoz JE. Quantitative endoscopic ultrasound elastography: an accurate method for the differentiation of solid pancreatic masses. Gastroenterology. 2010 Oct;139(4):1172-80. doi: 10.1053/j.gastro.2010.06.059. Epub 2010 Jun 27.
PMID: 20600020
citation: Dawwas MF, Taha H, Leeds JS, Nayar MK, Oppong KW. Diagnostic accuracy of quantitative EUS elastography for discriminating malignant from benign solid pancreatic masses: a prospective, single-center study. Gastrointest Endosc. 2012 Nov;76(5):953-61. doi: 10.1016/j.gie.2012.05.034. Epub 2012 Jul 31.
PMID: 22854060
citation: Giovannini M, Hookey LC, Bories E, Pesenti C, Monges G, Delpero JR. Endoscopic ultrasound elastography: the first step towards virtual biopsy? Preliminary results in 49 patients. Endoscopy. 2006 Apr;38(4):344-8. doi: 10.1055/s-2006-925158. Erratum In: Endoscopy. 2007 Mar;39(3):257.
PMID: 16680632
responsible party type: Sponsor