<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/NCT01677312</url>
  </required_header>
  <id_info>
    <org_study_id>356077</org_study_id>
    <nct_id>NCT01677312</nct_id>
  </id_info>
  <brief_title>Trial Comparing 19 and 25-gauge EUS-FNA Needles</brief_title>
  <acronym>EUS-FNA</acronym>
  <official_title>Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AdventHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the 19G and 25G needles for procuring tissue samples from the pancreas&#xD;
      during Endoscopic Ultrasound (EUS) procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study compares the median number of passes to establish a definitive diagnosis using the&#xD;
      19G or 25G needles. Also, the ability of both needles to procure a histological core tissue&#xD;
      is assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Median Number of Passes to Establish Diagnosis</measure>
    <time_frame>5 months</time_frame>
    <description>To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procurement of Histological Samples</measure>
    <time_frame>30 days</time_frame>
    <description>The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Needle Dysfunction</measure>
    <time_frame>2 hours</time_frame>
    <description>The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>30 days</time_frame>
    <description>The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cancer of Pancreas</condition>
  <condition>Pancreatic Neoplasm</condition>
  <arm_group>
    <arm_group_label>19G FNA needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25G FNA needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreatic Biopsy</intervention_name>
    <description>A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.</description>
    <arm_group_label>19G FNA needle</arm_group_label>
    <arm_group_label>25G FNA needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Histological Samples</intervention_name>
    <description>The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.</description>
    <arm_group_label>19G FNA needle</arm_group_label>
    <arm_group_label>25G FNA needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
        (1) Patients with solid pancreatic mass lesions.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Age &lt; 19 years&#xD;
&#xD;
          2. Unable to safely undergo EUS for any reason&#xD;
&#xD;
          3. Coagulopathy (INR &gt; 1.6, Prothrombin Time &gt; 18secs, Thrombocytopenia &lt; 80,000&#xD;
             cells/ml)&#xD;
&#xD;
          4. Unable to consent&#xD;
&#xD;
          5. Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shyam varadarajulu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Hospital Center for Interventional Endoscopy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>March 31, 2015</results_first_submitted>
  <results_first_submitted_qc>March 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</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>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>19G FNA Needle</title>
          <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
        </group>
        <group group_id="P2">
          <title>25G FNA Needle</title>
          <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>19G FNA Needle</title>
          <description>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.&#xD;
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.&#xD;
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.</description>
        </group>
        <group group_id="B2">
          <title>25G FNA Needle</title>
          <description>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.&#xD;
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.&#xD;
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="9.3"/>
                    <measurement group_id="B2" value="67.1" spread="11.5"/>
                    <measurement group_id="B3" value="67.3" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Median Number of Passes to Establish Diagnosis</title>
        <description>To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.</description>
        <time_frame>5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G FNA Needle</title>
            <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
          <group group_id="O2">
            <title>25G FNA Needle</title>
            <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Passes to Establish Diagnosis</title>
          <description>To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.</description>
          <units>No. of passes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procurement of Histological Samples</title>
        <description>The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G FNA Needle</title>
            <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
          <group group_id="O2">
            <title>25G FNA Needle</title>
            <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
        </group_list>
        <measure>
          <title>Procurement of Histological Samples</title>
          <description>The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.1"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Needle Dysfunction</title>
        <description>The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G FNA Needle</title>
            <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
          <group group_id="O2">
            <title>25G FNA Needle</title>
            <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
        </group_list>
        <measure>
          <title>Needle Dysfunction</title>
          <description>The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications</title>
        <description>The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G FNA Needle</title>
            <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
          <group group_id="O2">
            <title>25G FNA Needle</title>
            <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
          </group>
        </group_list>
        <measure>
          <title>Complications</title>
          <description>The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 days</time_frame>
      <desc>Telephone follow up conducted at 24 hours and 10 days post-procedure</desc>
      <group_list>
        <group group_id="E1">
          <title>19G FNA Needle</title>
          <description>19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
        </group>
        <group group_id="E2">
          <title>25G FNA Needle</title>
          <description>25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding and fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Shyam Varadarajulu, MD</name_or_title>
      <organization>Center for Interventional Endoscopy, Florida Hospital</organization>
      <phone>407-303-2570</phone>
      <email>svaradarajulu@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01677312
org study id: 356077
nct id: NCT01677312
lead sponsor: 
collaborator: 
has dmc: No
This study compares the 19G and 25G needles for procuring tissue samples from the pancreas
      during Endoscopic Ultrasound (EUS) procedures.
The study compares the median number of passes to establish a definitive diagnosis using the
      19G or 25G needles. Also, the ability of both needles to procure a histological core tissue
      is assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Median Number of Passes to Establish Diagnosis
time frame: 5 months
description: To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.
measure: Procurement of Histological Samples
time frame: 30 days
description: The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
measure: Needle Dysfunction
time frame: 2 hours
description: The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.
measure: Complications
time frame: 30 days
description: The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
arm group label: 19G FNA needle
arm group type: Active Comparator
description: Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
arm group label: 25G FNA needle
arm group type: Active Comparator
description: Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
intervention type: Procedure
intervention name: Pancreatic Biopsy
description: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
arm group label: 19G FNA needle
arm group label: 25G FNA needle
intervention type: Procedure
intervention name: Histological Samples
description: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
arm group label: 19G FNA needle
arm group label: 25G FNA needle
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: shyam varadarajulu, MD
role: Principal Investigator
affiliation: Florida Hospital Center for Interventional Endoscopy
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 