<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/NCT02198729</url>
  </required_header>
  <id_info>
    <org_study_id>HREC2013/10/4.2(3830)</org_study_id>
    <nct_id>NCT02198729</nct_id>
  </id_info>
  <brief_title>Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection</brief_title>
  <acronym>RESDEMR</acronym>
  <official_title>Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Michael Bourke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Sydney Local Health District</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have recently become proficient in a new, and we believe more effective&#xD;
      technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves&#xD;
      removing the polyp in one piece. It is preferable to remove the polyp in one piece as it&#xD;
      minimises the chance of leaving residual polyp tissue behind. There have also been recent&#xD;
      studies overseas that have shown this new technique to be quite effective. In this study,&#xD;
      half of the patients will receive the newly developed technique of polyp removal (ESD), while&#xD;
      the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This&#xD;
      study will allow us to show which technique results in lower recurrence rates and is more&#xD;
      effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EMR is a very effective procedure for lesions smaller than 20 mm. With this size the polyp&#xD;
      can be removed en bloc. En bloc resection is preferred as it minimises the likelihood of&#xD;
      residual adenoma and enhances histological assessment. It is also curative in superficially&#xD;
      invasive submucosal disease. It eliminates the need for surgery in these patients. With&#xD;
      lesions larger than 20 mm, the lesion is removed piece meal, often in more than 5 pieces.&#xD;
      Care is taken to ensure that no adenoma is left behind at the point of overlap between snare&#xD;
      resections. However, for every additional snare resection, there is the possibility that a&#xD;
      small amount of adenoma will be left behind at this overlap point. Overall, the literature&#xD;
      suggests that there is approximately a 15% residual adenoma rate at repeat colonoscopy in 3&#xD;
      months, which requires further treatment. With en bloc resection residual adenoma rate at&#xD;
      repeat colonoscopy in is close to 0%. This has to be balanced against the relative&#xD;
      inexperience with performing ESD, longer procedure time and higher complication rates. A&#xD;
      randomized trial near completion is comparing endoscopic snare resection with transanal&#xD;
      surgical resection for rectal polyps (24). Should this trial show that en bloc resection is&#xD;
      superior in achieving complete resection without recurrence at similar complication rates,&#xD;
      the endoscopic treatment strategy of large colorectal adenomas should be reconsidered. Since&#xD;
      en bloc resection is technically more challenging, this should have consequences for&#xD;
      credentialing, referral patterns and performance of removal of large colorectal polyps in&#xD;
      reference centers only. Thus, before en bloc resection is promoted as superior, and training&#xD;
      has to be intensified to comply with standards of safe oncologic resection of these lesions,&#xD;
      the efficacy and safety have to be proven in a comparative randomized trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2023</completion_date>
  <primary_completion_date type="Actual">May 2023</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>18 months</time_frame>
    <description>Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One piece resection rate</measure>
    <time_frame>14 days</time_frame>
    <description>Rate of en bloc resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success of EMR</measure>
    <time_frame>14 days</time_frame>
    <description>Rate of initial technical success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Recurrence tissue observed at follow up colonoscopies over a 3 year period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication rates</measure>
    <time_frame>14 days</time_frame>
    <description>Safety outcomes measured in the form of follow up phone calls.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Colonic Polyps</condition>
  <arm_group>
    <arm_group_label>Endoscopic Mucosal Resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic Submucosal Dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Submucosal Dissection</intervention_name>
    <arm_group_label>Endoscopic Submucosal Dissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Mucosal Resection</intervention_name>
    <arm_group_label>Endoscopic Mucosal Resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Can give informed consent to trial participation&#xD;
&#xD;
          -  Lesion size 20 mm to 50 mm&#xD;
&#xD;
          -  Laterally spreading or sessile polyp morphology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous resection or attempted resection of target adenoma lesion&#xD;
&#xD;
          -  Endoscopic appearance of invasive malignancy&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)&#xD;
&#xD;
          -  Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior&#xD;
             to procedure&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Grade IV-V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Bourke, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Sydney Local Health District</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westmead Endoscopy Unit</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Western Sydney Local Health District</investigator_affiliation>
    <investigator_full_name>Professor Michael Bourke</investigator_full_name>
    <investigator_title>Director of Gastrointestinal Endoscopy</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT02198729
org study id: HREC2013/10/4.2(3830)
nct id: NCT02198729
lead sponsor: 
has dmc: Yes
The investigators have recently become proficient in a new, and we believe more effective
      technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves
      removing the polyp in one piece. It is preferable to remove the polyp in one piece as it
      minimises the chance of leaving residual polyp tissue behind. There have also been recent
      studies overseas that have shown this new technique to be quite effective. In this study,
      half of the patients will receive the newly developed technique of polyp removal (ESD), while
      the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This
      study will allow us to show which technique results in lower recurrence rates and is more
      effective.
EMR is a very effective procedure for lesions smaller than 20 mm. With this size the polyp
      can be removed en bloc. En bloc resection is preferred as it minimises the likelihood of
      residual adenoma and enhances histological assessment. It is also curative in superficially
      invasive submucosal disease. It eliminates the need for surgery in these patients. With
      lesions larger than 20 mm, the lesion is removed piece meal, often in more than 5 pieces.
      Care is taken to ensure that no adenoma is left behind at the point of overlap between snare
      resections. However, for every additional snare resection, there is the possibility that a
      small amount of adenoma will be left behind at this overlap point. Overall, the literature
      suggests that there is approximately a 15% residual adenoma rate at repeat colonoscopy in 3
      months, which requires further treatment. With en bloc resection residual adenoma rate at
      repeat colonoscopy in is close to 0%. This has to be balanced against the relative
      inexperience with performing ESD, longer procedure time and higher complication rates. A
      randomized trial near completion is comparing endoscopic snare resection with transanal
      surgical resection for rectal polyps (24). Should this trial show that en bloc resection is
      superior in achieving complete resection without recurrence at similar complication rates,
      the endoscopic treatment strategy of large colorectal adenomas should be reconsidered. Since
      en bloc resection is technically more challenging, this should have consequences for
      credentialing, referral patterns and performance of removal of large colorectal polyps in
      reference centers only. Thus, before en bloc resection is promoted as superior, and training
      has to be intensified to comply with standards of safe oncologic resection of these lesions,
      the efficacy and safety have to be proven in a comparative randomized trial.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence
time frame: 18 months
description: Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations
measure: One piece resection rate
time frame: 14 days
description: Rate of en bloc resection
measure: Technical success of EMR
time frame: 14 days
description: Rate of initial technical success
measure: Recurrence
time frame: up to 3 years
description: Recurrence tissue observed at follow up colonoscopies over a 3 year period
measure: complication rates
time frame: 14 days
description: Safety outcomes measured in the form of follow up phone calls.
arm group label: Endoscopic Mucosal Resection
arm group type: Active Comparator
description: Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.
arm group label: Endoscopic Submucosal Dissection
arm group type: Experimental
description: Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.
intervention type: Procedure
intervention name: Endoscopic Submucosal Dissection
arm group label: Endoscopic Submucosal Dissection
intervention type: Procedure
intervention name: Endoscopic Mucosal Resection
arm group label: Endoscopic Mucosal Resection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michael J Bourke, MBBS
role: Principal Investigator
affiliation: Western Sydney Local Health District
facility: 
country: Australia
responsible party type: Sponsor-Investigator
investigator affiliation: Western Sydney Local Health District
investigator full name: Professor Michael Bourke
investigator title: Director of Gastrointestinal Endoscopy
mesh term: Polyps
mesh term: Colonic Polyps