<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/NCT03264092</url>
  </required_header>
  <id_info>
    <org_study_id>E17118</org_study_id>
    <nct_id>NCT03264092</nct_id>
  </id_info>
  <brief_title>Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.</brief_title>
  <official_title>Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center, El Paso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center, El Paso</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study's aim is to prospectively compare three different tissue acquisition techniques&#xD;
      during EUS guided solid lesions biopsies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for&#xD;
      the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal&#xD;
      mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range&#xD;
      of specimen adequacy when performing pancreatic biopsies with the standard fine needle&#xD;
      aspiration (FNA) needles with this modality. There are several factors that affect the&#xD;
      overall diagnostic yield of this procedure, such as endosonographer experience, presence of&#xD;
      cytopathologist during the procedure, the needle diameter and the number of passes. In this&#xD;
      study we will compare the yield of recently available fine biopsy needles (FNB) using three&#xD;
      different techniques to obtain samples from solid lesions. The three techniques to be&#xD;
      compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS).&#xD;
&#xD;
      wall cells.&#xD;
&#xD;
      In the &quot;suction technique&quot; the stylet of the needle can be left in place or removed before&#xD;
      puncturing the lesion. Once the needle is inside the target, negative pressure is applied&#xD;
      through a 10 or 20 cc syringe connected to the needle.&#xD;
&#xD;
      The wet suction technique consists of flushing of the needle with 5 ml of saline solution to&#xD;
      replace the column of air within the lumen of needle with saline solution before needle&#xD;
      aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc&#xD;
      syringe connected to the needle.&#xD;
&#xD;
      In the slow pull technique, the stylet is left in place in the needle and is slightly&#xD;
      retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is&#xD;
      pushed completely into the needle to remove any contaminant cells and several back and forth&#xD;
      movements are done while slowly withdrawing the stylet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Preliminary analysis of the results showed no statistically significant difference&#xD;
  </why_stopped>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score</measure>
    <time_frame>2 hours</time_frame>
    <description>0: inadequate&#xD;
limited cytological dx&#xD;
adquate cytological dx&#xD;
limited histological dx&#xD;
adequate histological dx with low quality&#xD;
adequate histological dx with high quality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Contamination Score of Each Specimen Obtained</measure>
    <time_frame>2 hours</time_frame>
    <description>This is based on the following scale&#xD;
Blood present&#xD;
Blood clots present</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Stratified Per the Number of Diagnostic Passes Required</measure>
    <time_frame>2 hours</time_frame>
    <description>This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Wet suction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry suction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slow pull</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic ultrasound guided fine needle biopsy</intervention_name>
    <description>Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
    <arm_group_label>Dry suction</arm_group_label>
    <arm_group_label>Slow pull</arm_group_label>
    <arm_group_label>Wet suction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages between 18-80 years old&#xD;
&#xD;
          2. Sex: male or female&#xD;
&#xD;
          3. Patients who require EUS and tissue sampling of solid solid lesions (size &gt;1 cm)&#xD;
             anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small&#xD;
             intestine, pancreas, liver, spleen or kidney.&#xD;
&#xD;
          4. Patients who are able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant female&#xD;
&#xD;
          2. Coagulation disorders (platelets &lt; 50,000/mm3, INR &gt; 2)&#xD;
&#xD;
          3. Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.&#xD;
&#xD;
          4. Cardiorespiratory dysfunction that precludes sedation.&#xD;
&#xD;
          5. Unable to provide informed 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>Antonio Mendoza Ladd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center, El Paso</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Tech university Health Sciences Center El Paso</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.</citation>
    <PMID>16322944</PMID>
  </reference>
  <reference>
    <citation>Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.</citation>
    <PMID>19117242</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>February 8, 2021</results_first_submitted>
  <results_first_submitted_qc>March 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 1, 2021</results_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Tech University Health Sciences Center, El Paso</investigator_affiliation>
    <investigator_full_name>Antonio Mendoza-Ladd</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03264092/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was terminated early given the difficulty we experienced enrolling patients.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Wet Suction</title>
          <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
        <group group_id="P2">
          <title>Dry Suction</title>
          <description>This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
        <group group_id="P3">
          <title>Slow Pull</title>
          <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=17&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wet Suction</title>
          <description>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
        <group group_id="B2">
          <title>Dry Suction</title>
          <description>This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
        <group group_id="B3">
          <title>Slow Pull</title>
          <description>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique&#xD;
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance</description>
        </group>
        <group group_id="B4">
          <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="17"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="55"/>
          </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="69" spread="13"/>
                    <measurement group_id="B2" value="64" spread="14"/>
                    <measurement group_id="B3" value="66" spread="10"/>
                    <measurement group_id="B4" value="66" spread="13"/>
                  </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="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score</title>
        <description>0: inadequate&#xD;
limited cytological dx&#xD;
adquate cytological dx&#xD;
limited histological dx&#xD;
adequate histological dx with low quality&#xD;
adequate histological dx with high quality</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wet Suction</title>
            <description>This arm describes the mean cellularity score obtained with the wet suction technique.</description>
          </group>
          <group group_id="O2">
            <title>Dry Suction</title>
            <description>This arm describes the mean cellularity score obtained with the dry suction technique.</description>
          </group>
          <group group_id="O3">
            <title>Slow Pull</title>
            <description>This arm describes the mean cellularity score obtained with the slow pull technique.</description>
          </group>
        </group_list>
        <measure>
          <title>Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score</title>
          <description>0: inadequate&#xD;
limited cytological dx&#xD;
adquate cytological dx&#xD;
limited histological dx&#xD;
adequate histological dx with low quality&#xD;
adequate histological dx with high quality</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="0.75"/>
                    <measurement group_id="O2" value="3.55" spread="0.76"/>
                    <measurement group_id="O3" value="3.28" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.</non_inferiority_desc>
            <p_value>0.18</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Contamination Score of Each Specimen Obtained</title>
        <description>This is based on the following scale&#xD;
Blood present&#xD;
Blood clots present</description>
        <time_frame>2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wet Suction</title>
            <description>This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the wet suction technique.</description>
          </group>
          <group group_id="O2">
            <title>Dry Suction</title>
            <description>This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the dry suction technique.</description>
          </group>
          <group group_id="O3">
            <title>Slow Pull</title>
            <description>This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the slow pull technique.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Contamination Score of Each Specimen Obtained</title>
          <description>This is based on the following scale&#xD;
Blood present&#xD;
Blood clots present</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood clot present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.</non_inferiority_desc>
            <p_value>0.41</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Stratified Per the Number of Diagnostic Passes Required</title>
        <description>This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.</description>
        <time_frame>2 hours</time_frame>
        <population>Diagnostic passes 4 and above were considered outside of protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Wet Suction</title>
            <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects</description>
          </group>
          <group group_id="O2">
            <title>Dry Suction</title>
            <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects</description>
          </group>
          <group group_id="O3">
            <title>Slow Pull</title>
            <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Stratified Per the Number of Diagnostic Passes Required</title>
          <description>This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.</description>
          <population>Diagnostic passes 4 and above were considered outside of protocol</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diagnostic pass 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic pass 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic pass 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic pass 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic pass 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic pass 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.</non_inferiority_desc>
            <p_value>0.45</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 hours</time_frame>
      <desc>Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov</desc>
      <group_list>
        <group group_id="E1">
          <title>Wet Suction</title>
          <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects</description>
        </group>
        <group group_id="E2">
          <title>Dry Suction</title>
          <description>This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects</description>
        </group>
        <group group_id="E3">
          <title>Slow Pull</title>
          <description>This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects&#xD;
\</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Bleeding from the puncture site.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Antonio Mendoza Ladd</name_or_title>
      <organization>Texas Tech University Health Sciences Center</organization>
      <phone>9152154678</phone>
      <email>antonio.mendoza-ladd@ttuhsc.edu</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/NCT03264092
org study id: E17118
nct id: NCT03264092
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study's aim is to prospectively compare three different tissue acquisition techniques
      during EUS guided solid lesions biopsies.
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for
      the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal
      mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range
      of specimen adequacy when performing pancreatic biopsies with the standard fine needle
      aspiration (FNA) needles with this modality. There are several factors that affect the
      overall diagnostic yield of this procedure, such as endosonographer experience, presence of
      cytopathologist during the procedure, the needle diameter and the number of passes. In this
      study we will compare the yield of recently available fine biopsy needles (FNB) using three
      different techniques to obtain samples from solid lesions. The three techniques to be
      compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS).

      wall cells.

      In the "suction technique" the stylet of the needle can be left in place or removed before
      puncturing the lesion. Once the needle is inside the target, negative pressure is applied
      through a 10 or 20 cc syringe connected to the needle.

      The wet suction technique consists of flushing of the needle with 5 ml of saline solution to
      replace the column of air within the lumen of needle with saline solution before needle
      aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc
      syringe connected to the needle.

      In the slow pull technique, the stylet is left in place in the needle and is slightly
      retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is
      pushed completely into the needle to remove any contaminant cells and several back and forth
      movements are done while slowly withdrawing the stylet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score
time frame: 2 hours
description: 0: inadequate
limited cytological dx
adquate cytological dx
limited histological dx
adequate histological dx with low quality
adequate histological dx with high quality
measure: Blood Contamination Score of Each Specimen Obtained
time frame: 2 hours
description: This is based on the following scale
Blood present
Blood clots present
measure: Number of Participants Stratified Per the Number of Diagnostic Passes Required
time frame: 2 hours
description: This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.
arm group label: Wet suction
arm group type: Experimental
description: This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
arm group label: Dry suction
arm group type: Experimental
description: This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique
arm group label: Slow pull
arm group type: Experimental
description: This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
intervention type: Procedure
intervention name: Endoscopic ultrasound guided fine needle biopsy
description: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
arm group label: Dry suction
arm group label: Slow pull
arm group label: Wet suction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Antonio Mendoza Ladd, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center, El Paso
facility: 
country: United States
citation: Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.
PMID: 16322944
citation: Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
PMID: 19117242
responsible party type: Principal Investigator
investigator affiliation: Texas Tech University Health Sciences Center, El Paso
investigator full name: Antonio Mendoza-Ladd
investigator title: Assistant Professor of Medicine
mesh term: Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 