<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/NCT01673334</url>
  </required_header>
  <id_info>
    <org_study_id>15779</org_study_id>
    <nct_id>NCT01673334</nct_id>
  </id_info>
  <brief_title>Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms</brief_title>
  <official_title>Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates&#xD;
      of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic&#xD;
      tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield&#xD;
      than core biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate&#xD;
      endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine&#xD;
      needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for&#xD;
      pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a&#xD;
      clear relationship between cellular elements and stroma which may be required for accurate&#xD;
      diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for&#xD;
      optimal yield which limits its dissemination and increases its cost. A novel EUS histology&#xD;
      needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate&#xD;
      diagnosis without the need for on site cytopathology assistance. Aim: To prospectively&#xD;
      compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA&#xD;
      and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all&#xD;
      primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of&#xD;
      solid pancreatic tumors will be screened for enrollment at either a preceding clinical&#xD;
      encounter or the morning of their scheduled procedure. English-speaking patients between the&#xD;
      ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas&#xD;
      will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly&#xD;
      cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo&#xD;
      both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care.&#xD;
      The results of the experimental approach (EUS-FNB) will be compared to the control approach&#xD;
      (EUS-FNA). Data collected for each procedure will include: instrument use order, number of&#xD;
      needle passes with each device, technical success of each device, complications, ease of use,&#xD;
      and the ultimate pathological diagnosis / diagnostic yield for each device. Each data&#xD;
      category will then be compared utilizing standard statistical tests including chi-squared,&#xD;
      Fishers' exact, or student's t test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>Phase 4</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Yield</measure>
    <time_frame>One-week post procedure</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pancreatic Tumor</condition>
  <arm_group>
    <arm_group_label>Fine Needle Aspiration and Core Biospsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fine Needle Aspiration (FNA) and Core biopsy (FNB)</intervention_name>
    <arm_group_label>Fine Needle Aspiration and Core Biospsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 and less than 90 years.&#xD;
&#xD;
          -  Presence of a solid (greater than 60%) mass lesion within the pancreas on&#xD;
             cross-sectional imaging, without a preceding tissue diagnosis.&#xD;
&#xD;
          -  Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT)&#xD;
             or partial thromboplastin time (PTT) that does not correct with the administration of&#xD;
             fresh frozen plasma.&#xD;
&#xD;
          -  The patient must read and speak english and has signed informed consent document.&#xD;
&#xD;
          -  The patient is scheduled for diagnostic endosonography by their referring provider or&#xD;
             UVa gastroenterologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 or greater than 90 years.&#xD;
&#xD;
          -  The patient is unable to read or understand the consent form.&#xD;
&#xD;
          -  The patient is currently pregnant.&#xD;
&#xD;
          -  The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin&#xD;
             time (PT) or partial thromboplastin time (PTT) which does not improve with&#xD;
             administration of fresh frozen plasma.&#xD;
&#xD;
          -  The patient has a pancreatic mass lesion which is predominantly cystic (greater than&#xD;
             40%).&#xD;
&#xD;
          -  No mass lesion is identified at the time of endosonography.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa Shami, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreas Tumor EUS FNA Core Biopsy Procore FNB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</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/NCT01673334
org study id: 15779
nct id: NCT01673334
lead sponsor: 
has dmc: Yes
We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates
      of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic
      tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield
      than core biopsy.
Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate
      endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine
      needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for
      pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a
      clear relationship between cellular elements and stroma which may be required for accurate
      diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for
      optimal yield which limits its dissemination and increases its cost. A novel EUS histology
      needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate
      diagnosis without the need for on site cytopathology assistance. Aim: To prospectively
      compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA
      and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all
      primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of
      solid pancreatic tumors will be screened for enrollment at either a preceding clinical
      encounter or the morning of their scheduled procedure. English-speaking patients between the
      ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas
      will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly
      cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo
      both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care.
      The results of the experimental approach (EUS-FNB) will be compared to the control approach
      (EUS-FNA). Data collected for each procedure will include: instrument use order, number of
      needle passes with each device, technical success of each device, complications, ease of use,
      and the ultimate pathological diagnosis / diagnostic yield for each device. Each data
      category will then be compared utilizing standard statistical tests including chi-squared,
      Fishers' exact, or student's t test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic Yield
time frame: One-week post procedure
arm group label: Fine Needle Aspiration and Core Biospsy
arm group type: Experimental
description: Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.
intervention type: Device
intervention name: Fine Needle Aspiration (FNA) and Core biopsy (FNB)
arm group label: Fine Needle Aspiration and Core Biospsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Vanessa Shami, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Pancreatic Neoplasms