<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/NCT03000868</url>
  </required_header>
  <id_info>
    <org_study_id>CNUH-2016-252</org_study_id>
    <nct_id>NCT03000868</nct_id>
  </id_info>
  <brief_title>Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR</brief_title>
  <official_title>Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic&#xD;
      mucosal resection with hot endoscopic mucosal resection. Half of the participants will&#xD;
      receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic&#xD;
      mucosal resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal polyps are considered as precancerous lesions and endoscopical resection is&#xD;
      currently the treatment of choice when it is possible.&#xD;
&#xD;
      Colorectal polyps are classified into diminutive polyps (&lt;5mm in diameter), small polyps&#xD;
      (6-9mm in diameter), and large polyps (&gt;1cm in diameter). There are several endoscopical&#xD;
      treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy&#xD;
      forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold&#xD;
      polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the&#xD;
      use of electrocautery, and hot polypectomy means removal of the polyp with the use of&#xD;
      electocautery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants were enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 26, 2018</completion_date>
  <primary_completion_date type="Actual">July 26, 2018</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 removal of the colorectal polyp</measure>
    <time_frame>At the time of the procedure (endoscopic mucosal resection)</time_frame>
    <description>The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>At the time of the procedure (endoscopic mucosal resection)</time_frame>
    <description>The time needed for the hot EMR vs cold EMR (minutes) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication after endoscopic mucosal resection</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Colonic Polyps</condition>
  <arm_group>
    <arm_group_label>Cold EMR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who have small colorectal polyps (&lt;1cm) who receive endoscopic mucosal resection using snare without electrocautery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hot EMR group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who have small colorectal polyps (&lt;1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold endoscopic mucosal resection</intervention_name>
    <description>Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (&lt;1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.</description>
    <arm_group_label>Cold EMR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hot endoscopic mucosal resection</intervention_name>
    <description>Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (&lt;1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.</description>
    <arm_group_label>Hot EMR group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with colorectal polyps that are &lt;1cm in diameter who need endoscopic mucosal&#xD;
             resection.&#xD;
&#xD;
               -  Patients who gave informed consents to this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 19&#xD;
&#xD;
          -  Patients who are receiving antiplatelet or anticoagulant therapies&#xD;
&#xD;
          -  Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal&#xD;
             disease, or chronic kidney disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-hwan Park, M.D., Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Horiuchi A, Makino T, Ichise Y, Kajiyama M, Kato N, Tanaka N. Comparison of newly found polyps after removal of small colorectal polyps with cold or hot snare polypectomy. Acta Gastroenterol Belg. 2015 Dec;78(4):406-10.</citation>
    <PMID>26712051</PMID>
  </reference>
  <reference>
    <citation>Lee SH, Shin SJ, Park DI, Kim SE, Hong SP, Hong SN, Yang DH, Lee BI, Kim YH, Kim HS, Yang SK, Kim HJ, Kim SH, Kim HJ; Multi-Society Task Force for Development of Guidelines for Colorectal Polyp Screening, Surveillance and Management. [Korean guidelines for colonoscopic polypectomy]. Korean J Gastroenterol. 2012 Feb;59(2):85-98. doi: 10.4166/kjg.2012.59.2.85. Korean.</citation>
    <PMID>22387834</PMID>
  </reference>
  <reference>
    <citation>Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.</citation>
    <PMID>24125514</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Chang Hwan Park</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Colonic Polyps</keyword>
  <keyword>Endoscopic Mucosal Resection</keyword>
  <keyword>Colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data are not planned to be shared to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000868
org study id: CNUH-2016-252
nct id: NCT03000868
lead sponsor: 
has dmc: No
This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic
      mucosal resection with hot endoscopic mucosal resection. Half of the participants will
      receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic
      mucosal resection.
Colorectal polyps are considered as precancerous lesions and endoscopical resection is
      currently the treatment of choice when it is possible.

      Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps
      (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical
      treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy
      forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold
      polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the
      use of electrocautery, and hot polypectomy means removal of the polyp with the use of
      electocautery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete removal of the colorectal polyp
time frame: At the time of the procedure (endoscopic mucosal resection)
description: The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
measure: Procedure time
time frame: At the time of the procedure (endoscopic mucosal resection)
description: The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
measure: Complication after endoscopic mucosal resection
time frame: Within 1 month
description: Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.
arm group label: Cold EMR group
arm group type: Experimental
description: Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.
arm group label: Hot EMR group
arm group type: Active Comparator
description: Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.
intervention type: Procedure
intervention name: Cold endoscopic mucosal resection
description: Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
arm group label: Cold EMR group
intervention type: Procedure
intervention name: Hot endoscopic mucosal resection
description: Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
arm group label: Hot EMR group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Chang-hwan Park, M.D., Ph.D
role: Study Director
affiliation: Chonnam National University Hospital
facility: 
country: Korea, Republic of
citation: Horiuchi A, Makino T, Ichise Y, Kajiyama M, Kato N, Tanaka N. Comparison of newly found polyps after removal of small colorectal polyps with cold or hot snare polypectomy. Acta Gastroenterol Belg. 2015 Dec;78(4):406-10.
PMID: 26712051
citation: Lee SH, Shin SJ, Park DI, Kim SE, Hong SP, Hong SN, Yang DH, Lee BI, Kim YH, Kim HS, Yang SK, Kim HJ, Kim SH, Kim HJ; Multi-Society Task Force for Development of Guidelines for Colorectal Polyp Screening, Surveillance and Management. [Korean guidelines for colonoscopic polypectomy]. Korean J Gastroenterol. 2012 Feb;59(2):85-98. doi: 10.4166/kjg.2012.59.2.85. Korean.
PMID: 22387834
citation: Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PMID: 24125514
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Chang Hwan Park
investigator title: Professor
mesh term: Polyps
mesh term: Colonic Polyps
sharing ipd: No
ipd description: Individual participant data are not planned to be shared to other researchers.