<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/NCT02239536</url>
  </required_header>
  <id_info>
    <org_study_id>XC14TIMI0039K</org_study_id>
    <nct_id>NCT02239536</nct_id>
  </id_info>
  <brief_title>Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps</brief_title>
  <acronym>HSPvsHSPASI</acronym>
  <official_title>Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bo-In Lee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Vincent's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Incheon St.Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The complete removal of colorectal polyp is required to prevent tumor recurrence and&#xD;
      development of potential interval cancers. However, several studies have shown high&#xD;
      incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5&#xD;
      mm. The polypectomy techniques using hot snare are usually used for the removal of these&#xD;
      polyps. However, the optimal technique for complete resection of these polyps is unknown.&#xD;
      There are few data comparing hot snare polypectomy with hot snare polypectomy after saline&#xD;
      injection for complete resection of colorectal polyps (5mm or larger). The aim of this study&#xD;
      is to compare hot snare polypectomy with hot snare polypectomy after saline injection for&#xD;
      removal of 5-10mm sized colorectal polyps.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Resection Rate</measure>
    <time_frame>2 weeks after</time_frame>
    <description>Complete resection was defined as the absence of residual polyp in the resection margin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lateral Margin</measure>
    <time_frame>2 weeks after</time_frame>
    <description>Observation of maring on a recsected specimen</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">362</enrollment>
  <condition>Polyp of Large Intestine</condition>
  <arm_group>
    <arm_group_label>Hot snare polypectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hot snare polypectomy(saline injection)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hot snare polypectomy</intervention_name>
    <description>hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
    <arm_group_label>Hot snare polypectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hot snare polypectomy after saline injection</intervention_name>
    <description>hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</description>
    <arm_group_label>Hot snare polypectomy(saline injection)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 30&#xD;
&#xD;
          -  5~10mm sized colorectal polyps&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)&#xD;
&#xD;
          -  Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant&#xD;
             therapy&#xD;
&#xD;
          -  ASA class III or more&#xD;
&#xD;
          -  Any condition which, in the opinion of the Investigator, places the patient at&#xD;
             unacceptable risk if he/she were to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo-In Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Gastroenterology; Seoul St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27.</citation>
    <PMID>29250580</PMID>
  </reference>
  <reference>
    <citation>Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.</citation>
    <PMID>25708763</PMID>
  </reference>
  <reference>
    <citation>Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.</citation>
    <PMID>28970290</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>July 17, 2019</results_first_submitted>
  <results_first_submitted_qc>April 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2020</results_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Bo-In Lee</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>neoplastic colorectal polyp</keyword>
  <keyword>hot snare polypectomy</keyword>
  <keyword>hot snare polypectomy after saline injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</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>August 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02239536/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were excluded if they have (1) a bleeding tendency or ever taken antiplatelet or anticoagulation therapy within 1 week before undergoing the procedure, (2) An inflammatory bowel disease, (3) a polyposis syndrome, or (4) an inability to provide informed consent.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Hot Snare Polypectomy</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique&#xD;
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
        </group>
        <group group_id="P2">
          <title>Hot Snare Polypectomy(Saline Injection)</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique&#xD;
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Non-neoplastic polyp</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hot Snare Polypectomy</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique&#xD;
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
        </group>
        <group group_id="B2">
          <title>Hot Snare Polypectomy(Saline Injection)</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique&#xD;
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</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="167"/>
            <count group_id="B2" value="155"/>
            <count group_id="B3" value="322"/>
          </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="62.8" spread="10.7"/>
                    <measurement group_id="B2" value="63.0" spread="10.8"/>
                    <measurement group_id="B3" value="62.9" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="110"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="167"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="322"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="167"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="322"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Resection Rate</title>
        <description>Complete resection was defined as the absence of residual polyp in the resection margin</description>
        <time_frame>2 weeks after</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hot Snare Polypectomy</title>
            <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique&#xD;
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
          </group>
          <group group_id="O2">
            <title>Hot Snare Polypectomy(Saline Injection)</title>
            <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique&#xD;
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Resection Rate</title>
          <description>Complete resection was defined as the absence of residual polyp in the resection margin</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete resection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incomplete resection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lateral Margin</title>
        <description>Observation of maring on a recsected specimen</description>
        <time_frame>2 weeks after</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hot Snare Polypectomy</title>
            <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique&#xD;
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
          </group>
          <group group_id="O2">
            <title>Hot Snare Polypectomy(Saline Injection)</title>
            <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique&#xD;
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</description>
          </group>
        </group_list>
        <measure>
          <title>Lateral Margin</title>
          <description>Observation of maring on a recsected specimen</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inconclusive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="37"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks after polypectomy</time_frame>
      <desc>Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).</desc>
      <group_list>
        <group group_id="E1">
          <title>Hot Snare Polypectomy</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique&#xD;
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps</description>
        </group>
        <group group_id="E2">
          <title>Hot Snare Polypectomy(Saline Injection)</title>
          <description>Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique&#xD;
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps</description>
        </group>
      </group_list>
      <serious_events>
        <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="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Perforation</sub_title>
                <description>Situations that require surgical treatment due to mucosal defects</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Immediate bleeding</sub_title>
                <description>continuous bleeding over 30 seconds requiring any form of endoscopic hemostasis (epinephrine injection, clipping or coagulation)</description>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="167"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Delayed bleeding</sub_title>
                <description>bleeding from the post-polypectomy site between 24 hours and 2 weeks after polypectomy</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Post-polypectomy syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </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>Bo-In Lee</name_or_title>
      <organization>Seoul ST. Mary's hospital</organization>
      <phone>821083671055</phone>
      <email>gidoc4u@gmail.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/NCT02239536
org study id: XC14TIMI0039K
nct id: NCT02239536
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The complete removal of colorectal polyp is required to prevent tumor recurrence and
      development of potential interval cancers. However, several studies have shown high
      incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5
      mm. The polypectomy techniques using hot snare are usually used for the removal of these
      polyps. However, the optimal technique for complete resection of these polyps is unknown.
      There are few data comparing hot snare polypectomy with hot snare polypectomy after saline
      injection for complete resection of colorectal polyps (5mm or larger). The aim of this study
      is to compare hot snare polypectomy with hot snare polypectomy after saline injection for
      removal of 5-10mm sized colorectal polyps.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Resection Rate
time frame: 2 weeks after
description: Complete resection was defined as the absence of residual polyp in the resection margin
measure: Lateral Margin
time frame: 2 weeks after
description: Observation of maring on a recsected specimen
arm group label: Hot snare polypectomy
arm group type: Experimental
description: Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
arm group label: Hot snare polypectomy(saline injection)
arm group type: Experimental
description: Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
intervention type: Procedure
intervention name: hot snare polypectomy
description: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
arm group label: Hot snare polypectomy
intervention type: Procedure
intervention name: hot snare polypectomy after saline injection
description: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
arm group label: Hot snare polypectomy(saline injection)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bo-In Lee
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
facility: 
country: Korea, Republic of
citation: Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27.
PMID: 29250580
citation: Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
PMID: 25708763
citation: Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.
PMID: 28970290
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Bo-In Lee
investigator title: MD, PhD
mesh term: Polyps
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 