<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/NCT01673945</url>
  </required_header>
  <id_info>
    <org_study_id>P69/CE/2011</org_study_id>
    <nct_id>NCT01673945</nct_id>
  </id_info>
  <brief_title>FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions</brief_title>
  <official_title>Forward Viewing US Endoscope Versus Standard Viewing US Endoscope in the Performance of EUS-guided Fine Needle Aspiration of Solid Lesions of the Gastrointestinal Tract and of Adjacent Organs: A Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in&#xD;
      the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent&#xD;
      organs, with the aim of establishing for which lesions and from which location the capability&#xD;
      of the FV-EUS will be superior, equal or, inferior to the CLA-EUS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of&#xD;
      potentially expanding the therapeutic applications of EUS. This prototype is a modification&#xD;
      of the CLA scope and it is characterized primarily by a shifting of the orientation of the&#xD;
      endoscopic and US views from oblique to forward. The US transducer is located adjacent to the&#xD;
      working channel, at the endoscope tip, to display a forward-viewing image along to a scanning&#xD;
      plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm&#xD;
      working channel without elevator, which allows exit of the FNA needle or any other accessory&#xD;
      used parallel to the longitudinal axis of the scope.&#xD;
&#xD;
      Preliminary experiences with this scope have reported potential advantages over the&#xD;
      conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary&#xD;
      strictures. Moreover, a large experience still unpublished from the Catholic University,&#xD;
      Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI&#xD;
      tract has shown the FV-EUS to be highly effective with a performance that seems at least&#xD;
      comparable to that of the CLA-EUS. To date, however, no data comparing the performance of&#xD;
      both scopes for FNA of target lesions are available to better clarify the advantages and&#xD;
      disadvantages of one scope over the other.&#xD;
&#xD;
      We designed a randomized comparative trial in which patients will be randomized to undergo&#xD;
      examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the&#xD;
      presumed lesion; (ii) failure in performing the FNA with the scope used based on&#xD;
      randomization, a second attempt will be made using the other scope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA</measure>
    <time_frame>6 months</time_frame>
    <description>(i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA</measure>
    <time_frame>6 months</time_frame>
    <description>sensitivity, specificity, and diagnostic accuracy of EUS-FNA performed with the two different EUS scopes in the evaluation of solid lesions will be determined and compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Ease of the procedure will be graded on a analog 5 point score as listed in the table below.&#xD;
Physician will be asked to answer the following questions:&#xD;
Ease of visualization?&#xD;
Ease of puncturing?&#xD;
Ease of moving back and forth inside the lesion?&#xD;
Ease of overall procedure?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications</measure>
    <time_frame>1 month</time_frame>
    <description>Rate of bleeding, pancreatitis, infection and perforation for each procedure will be measured by observation of the patient in the recovery area soonafter and one hour after completion of the procedure. The rate of pancreatitis and infection rate will be also assessed at 24 hours by visiting or calling the patients if discharged</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Solid Lesions of the GI Tract or of Adjacent Organs</condition>
  <arm_group>
    <arm_group_label>EUS-FNA with the CLA-EUS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients examined with the CLA-EUS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EUS-FNA With the FV-EUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients examined with the FV-EUS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS-guided fine needle aspiration</intervention_name>
    <description>Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference</description>
    <arm_group_label>EUS-FNA With the FV-EUS</arm_group_label>
    <arm_group_label>EUS-FNA with the CLA-EUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of a solid lesion in the GI tract or in one of the adjacent organs identified&#xD;
             at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because&#xD;
             unresectable or because tissue characterization is needed to decide further treatment&#xD;
             modalities&#xD;
&#xD;
          2. Age greater than 18.&#xD;
&#xD;
          3. Absence of histological or cytological confirmation of malignancy.&#xD;
&#xD;
          4. Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active coagulopathy that cannot be corrected after administration of&#xD;
             plasma.&#xD;
&#xD;
          2. Resectable lesions that does not need tissue characterization to decide treatment&#xD;
             modalities.&#xD;
&#xD;
          3. Pregnancy.&#xD;
&#xD;
          4. Patients who cannot give inform consent.&#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>Alberto Larghi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universita' del Sacro Cuore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasme University Hospital</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita' del Sacro Cuore</name>
      <address>
        <city>Rome</city>
        <zip>00136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Amsterdam medical center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Guido Costamagna</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>EUS-FNA, Forward viewing EUS scope, Curvilinear EUS scope</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/NCT01673945
org study id: P69/CE/2011
nct id: NCT01673945
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in
      the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent
      organs, with the aim of establishing for which lesions and from which location the capability
      of the FV-EUS will be superior, equal or, inferior to the CLA-EUS
Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of
      potentially expanding the therapeutic applications of EUS. This prototype is a modification
      of the CLA scope and it is characterized primarily by a shifting of the orientation of the
      endoscopic and US views from oblique to forward. The US transducer is located adjacent to the
      working channel, at the endoscope tip, to display a forward-viewing image along to a scanning
      plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm
      working channel without elevator, which allows exit of the FNA needle or any other accessory
      used parallel to the longitudinal axis of the scope.

      Preliminary experiences with this scope have reported potential advantages over the
      conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary
      strictures. Moreover, a large experience still unpublished from the Catholic University,
      Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI
      tract has shown the FV-EUS to be highly effective with a performance that seems at least
      comparable to that of the CLA-EUS. To date, however, no data comparing the performance of
      both scopes for FNA of target lesions are available to better clarify the advantages and
      disadvantages of one scope over the other.

      We designed a randomized comparative trial in which patients will be randomized to undergo
      examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the
      presumed lesion; (ii) failure in performing the FNA with the scope used based on
      randomization, a second attempt will be made using the other scope.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA
time frame: 6 months
description: (i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.
measure: Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA
time frame: 6 months
description: sensitivity, specificity, and diagnostic accuracy of EUS-FNA performed with the two different EUS scopes in the evaluation of solid lesions will be determined and compared
measure: Ease of procedure
time frame: 6 months
description: Ease of the procedure will be graded on a analog 5 point score as listed in the table below.
Physician will be asked to answer the following questions:
Ease of visualization?
Ease of puncturing?
Ease of moving back and forth inside the lesion?
Ease of overall procedure?
measure: Rate of complications
time frame: 1 month
description: Rate of bleeding, pancreatitis, infection and perforation for each procedure will be measured by observation of the patient in the recovery area soonafter and one hour after completion of the procedure. The rate of pancreatitis and infection rate will be also assessed at 24 hours by visiting or calling the patients if discharged
arm group label: EUS-FNA with the CLA-EUS
arm group type: Active Comparator
description: patients examined with the CLA-EUS
arm group label: EUS-FNA With the FV-EUS
arm group type: Experimental
description: patients examined with the FV-EUS
intervention type: Device
intervention name: EUS-guided fine needle aspiration
description: Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference
arm group label: EUS-FNA With the FV-EUS
arm group label: EUS-FNA with the CLA-EUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alberto Larghi, MD
role: Principal Investigator
affiliation: Universita' del Sacro Cuore
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Guido Costamagna
investigator title: Professor of Surgery