<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/NCT03245580</url>
  </required_header>
  <id_info>
    <org_study_id>PRC17-0714</org_study_id>
    <nct_id>NCT03245580</nct_id>
  </id_info>
  <brief_title>Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)</brief_title>
  <acronym>BLOCS</acronym>
  <official_title>Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parkview Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parkview Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this prospective, randomized, multicenter study is to evaluate and&#xD;
      compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2&#xD;
      different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques:&#xD;
      &quot;modified Wet suction&quot; and &quot;Slow pull&quot; technique of collecting tissue from a liver biopsy via&#xD;
      Endoscopic Ultrasound (EUS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will have a biopsy performed via one of 2 different techniques: &quot;modified wet&#xD;
      suction&quot;, or &quot;slow pull&quot; technique. A randomization process will determine which technique.&#xD;
      Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the&#xD;
      right and left lobe of the liver.&#xD;
&#xD;
      Quality of tissue obtained via the 2 different techniques will be evaluated by number of&#xD;
      fragments, length of specimens and number of tracts observed by the local pathologist and&#xD;
      compared between the tissues obtained from the two techniques. .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 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>
    <intervention_model_description>prospective, randomized, multicenter study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathological Yield Fragmentation</measure>
    <time_frame>At day 7 post biopsy</time_frame>
    <description>To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological Yield Length</measure>
    <time_frame>At time of completion of pathology report</time_frame>
    <description>To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological Yield Quantity</measure>
    <time_frame>At time of completion of pathology report</time_frame>
    <description>To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Complications occurring at time of consent, at procedure time and at day 7 post procedure</time_frame>
    <description>Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Arm 1 -modified wet suction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2- Slow Pull</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Core Liver Biopsy</intervention_name>
    <description>Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
    <arm_group_label>Arm 1 -modified wet suction</arm_group_label>
    <arm_group_label>Arm 2- Slow Pull</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying&#xD;
             liver disease or to determine stage, grade and presence of fibrosis for suspected&#xD;
             benign etiology.&#xD;
&#xD;
          -  History of abnormal LFTs&#xD;
&#xD;
          -  Documented history of chronic liver disease&#xD;
&#xD;
          -  Question of underlying liver disease as cause of abnormal imaging or symptoms which&#xD;
             may be attributed to liver disorder&#xD;
&#xD;
          -  Fatty liver disease&#xD;
&#xD;
          -  Subjects 18 years of age or older&#xD;
&#xD;
          -  Subject must be able to hold anticoagulants as per institutional standard of care&#xD;
&#xD;
          -  Subjects must be deemed physically able to undergo anesthesia. This includes either&#xD;
             Monitored Anesthesia Care (MAC) or general anesthesia.&#xD;
&#xD;
          -  Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to&#xD;
             participate in the study and have signed Informed Consent&#xD;
&#xD;
          -  Women of child bearing potential who are not pregnant as proven by a negative&#xD;
             pregnancy test may be included.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subjects that are unable to tolerate anesthesia for the procedure&#xD;
&#xD;
          -  Subjects 17 or under&#xD;
&#xD;
          -  Subjects whose anticoagulants cannot be held&#xD;
&#xD;
          -  Subjects who cannot have or refuse EUS guided procedure&#xD;
&#xD;
          -  Subjects who are pregnant&#xD;
&#xD;
          -  INR &gt;1.5&#xD;
&#xD;
          -  Platelets 50,000 or less&#xD;
&#xD;
          -  Subjects requiring control of bleeding on initial upper endoscopy&#xD;
&#xD;
          -  Subjects requiring endoscopic mucosal resection&#xD;
&#xD;
          -  Subjects with large volume ascites&#xD;
&#xD;
          -  Subjects requiring pancreatic biopsies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil R Sharma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>parkview cancer institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa CLara Valley Medical Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Regional Medical Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oschner Health System</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>December 17, 2021</results_first_submitted>
  <results_first_submitted_qc>March 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2022</results_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parkview Health</investigator_affiliation>
    <investigator_full_name>Neil Sharma, M.D.</investigator_full_name>
    <investigator_title>President, Parkview Cancer Institute;Director Advanced Interventional Endoscopy &amp; Endoscopic Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</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>February 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03245580/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1 -Modified Wet Suction</title>
          <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
        </group>
        <group group_id="P2">
          <title>Arm 2- Slow Pull</title>
          <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="78"/>
              </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>Arm 1 -Modified Wet Suction</title>
          <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
        </group>
        <group group_id="B2">
          <title>Arm 2- Slow Pull</title>
          <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</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="75"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="153"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.1" lower_limit="46.8" upper_limit="63.3"/>
                    <measurement group_id="B2" value="56.6" lower_limit="48.4" upper_limit="64.1"/>
                    <measurement group_id="B3" value="55.85" lower_limit="46.8" upper_limit="64.1"/>
                  </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="60"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="49"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="131"/>
                  </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="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </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="75"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anticoagulants/Antiplatelet Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pathological Yield Fragmentation</title>
        <description>To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.</description>
        <time_frame>At day 7 post biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 -Modified Wet Suction</title>
            <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2- Slow Pull</title>
            <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathological Yield Fragmentation</title>
          <description>To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Total number liver biopsy specimens</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Total number liver biopsy specimens</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Length of Longest Fragment- Left Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="11" upper_limit="20"/>
                    <measurement group_id="O2" value="11" lower_limit="6" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length of Longest Fragment- Right Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="9" upper_limit="19"/>
                    <measurement group_id="O2" value="10" lower_limit="8" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pathological Yield Length</title>
        <description>To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.</description>
        <time_frame>At time of completion of pathology report</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 -Modified Wet Suction</title>
            <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2- Slow Pull</title>
            <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathological Yield Length</title>
          <description>To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of liver biopsy specimens</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of liver biopsy specimens</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Length of Fragments - Left Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.5" lower_limit="31" upper_limit="71"/>
                    <measurement group_id="O2" value="34.5" lower_limit="17" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Length of Fragments-Right Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" lower_limit="22" upper_limit="60"/>
                    <measurement group_id="O2" value="28" lower_limit="17" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pathological Yield Quantity</title>
        <description>To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.</description>
        <time_frame>At time of completion of pathology report</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 -Modified Wet Suction</title>
            <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2- Slow Pull</title>
            <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathological Yield Quantity</title>
          <description>To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a &quot;modified wet suction,&quot; and &quot;slow pull&quot; techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.</description>
          <units>Number of portal tracts</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of liver biopsy specimens</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of liver biopsy specimens</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of Portal Tracts Left Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="12" upper_limit="24.5"/>
                    <measurement group_id="O2" value="11.5" lower_limit="6.5" upper_limit="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Number of Portal Tracts Right Lobe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="10" upper_limit="18"/>
                    <measurement group_id="O2" value="12" lower_limit="7" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications</title>
        <description>Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.</description>
        <time_frame>Complications occurring at time of consent, at procedure time and at day 7 post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 -Modified Wet Suction</title>
            <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2- Slow Pull</title>
            <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Complications</title>
          <description>Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.</description>
          <units>Number of Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Minor Adverse Events Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor Adverse Events Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor Adverse Events Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collected for one week following procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1 -Modified Wet Suction</title>
          <description>Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
        </group>
        <group group_id="E2">
          <title>Arm 2- Slow Pull</title>
          <description>Intervention: Procedure Core Liver Biopsy Technique: Slow Pull&#xD;
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Intraabdominal Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <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="13" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Bronchial Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Fall from bed</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Shortness of Breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </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>Christina Zelt RN</name_or_title>
      <organization>Parkview Mirro Research Center</organization>
      <phone>2602664153</phone>
      <email>christina.zelt@parkview.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/NCT03245580
org study id: PRC17-0714
nct id: NCT03245580
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The primary purpose of this prospective, randomized, multicenter study is to evaluate and
      compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2
      different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques:
      "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via
      Endoscopic Ultrasound (EUS).
Each subject will have a biopsy performed via one of 2 different techniques: "modified wet
      suction", or "slow pull" technique. A randomization process will determine which technique.
      Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the
      right and left lobe of the liver.

      Quality of tissue obtained via the 2 different techniques will be evaluated by number of
      fragments, length of specimens and number of tracts observed by the local pathologist and
      compared between the tissues obtained from the two techniques. .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, multicenter study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pathological Yield Fragmentation
time frame: At day 7 post biopsy
description: To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
measure: Pathological Yield Length
time frame: At time of completion of pathology report
description: To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
measure: Pathological Yield Quantity
time frame: At time of completion of pathology report
description: To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.
measure: Complications
time frame: Complications occurring at time of consent, at procedure time and at day 7 post procedure
description: Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
arm group label: Arm 1 -modified wet suction
arm group type: Other
description: Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
arm group label: Arm 2- Slow Pull
arm group type: Other
description: Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
intervention type: Diagnostic Test
intervention name: Core Liver Biopsy
description: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
arm group label: Arm 1 -modified wet suction
arm group label: Arm 2- Slow Pull
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil R Sharma, MD
role: Principal Investigator
affiliation: parkview cancer institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Parkview Health
investigator full name: Neil Sharma, M.D.
investigator title: President, Parkview Cancer Institute;Director Advanced Interventional Endoscopy & Endoscopic Oncology
mesh term: Liver Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 