<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/NCT02967107</url>
  </required_header>
  <id_info>
    <org_study_id>HREC/15/WMEAD/507</org_study_id>
    <nct_id>NCT02967107</nct_id>
  </id_info>
  <brief_title>Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps</brief_title>
  <acronym>CSP-EMR</acronym>
  <official_title>Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Sydney Local Health District</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>
      Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) is the third most common cancer and it remains the second most&#xD;
      commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence&#xD;
      and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has&#xD;
      proven to be effective in reducing mortality and morbidity from CRC and has become common&#xD;
      practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy)&#xD;
      occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete&#xD;
      adenoma resection.&#xD;
&#xD;
      The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor&#xD;
      lesions are thought to be a major contributor to the relative failure of colonoscopy in the&#xD;
      prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the&#xD;
      period after complete colonoscopy and prior to surveillance, termed 'interval' cancer.&#xD;
&#xD;
      In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to&#xD;
      be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of&#xD;
      SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas,&#xD;
      and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have&#xD;
      indistinct margins, and smaller lesions may prove difficult to entrap with the snare because&#xD;
      of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an&#xD;
      endoscopic appearance indistinguishable from conventional adenomas, and the surrounding&#xD;
      serrated component may be overlooked and incompletely resected if this is not recognized.&#xD;
&#xD;
      The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes&#xD;
      with regard to polyp detection rate, complete resection rate (CRR) of polyps, patient&#xD;
      comfort, safety and cost-efficacy. Although colonoscopy is considered the 'gold standard' for&#xD;
      detecting and removing polyps, the technique is still imperfect. Questions about best&#xD;
      practice for polypectomy remain, so optimizing the technique is expected to lead to better&#xD;
      patient outcomes. The optimal treatment of SSPs should be effective, safe and inexpensive.&#xD;
&#xD;
      Such lesions can be removed by cold snare polypectomy or by endoscopic mucosal resection.&#xD;
      Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective&#xD;
      technique for removal of any small polyps (&lt;10 mm). Because of their physical&#xD;
      characteristics, use of thin wire snares leads to a fast tissue transection and ability to&#xD;
      remove SSP relatively swiftly. The size of snares suitable for SSP CSP is approximately 9 mm.&#xD;
      Thus lesions greater than this size would need to be removed in more than one piece,&#xD;
      introducing the possibility of incomplete resection. Endoscopic mucosal resection (EMR) is&#xD;
      well established for laterally spreading colorectal lesions. It involves submucosal injection&#xD;
      and diathermy assisted snare resection by piecemeal or en-bloc depending on polyp size. En&#xD;
      bloc resection is possible for lesions up to 20 mm and facilitates histopathological&#xD;
      evaluation. EMR is more time consuming than CSP and may be associated with diathermy related&#xD;
      complications such as postpolypectomy bleeding, perforation and pain. The most efficient and&#xD;
      safe method of removal of SSP has not been established.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">August 2022</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy</measure>
    <time_frame>4-6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Pain after EMR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">474</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Cold snare polypectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic mucosal resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold snare polypectomy</intervention_name>
    <description>Use of a polypectomy snare closed over a polyp without electrocautery</description>
    <arm_group_label>Cold snare polypectomy</arm_group_label>
    <other_name>CSP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic mucosal resection</intervention_name>
    <description>Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery</description>
    <arm_group_label>Endoscopic mucosal resection</arm_group_label>
    <other_name>EMR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Patients able to give informed consent to involvement in trial. For patients who do&#xD;
             not speak English, an interpreter will be asked to translate the informed consent&#xD;
&#xD;
          -  Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for&#xD;
             all indications&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic&#xD;
             features of malignancy&#xD;
&#xD;
          -  At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the&#xD;
             proceduralist, can be removed safely using either CSP or EMR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of antiplatelets (excluding aspirin) or anticoagulants which have not&#xD;
             appropriately been interrupted according to the guidelines [21]&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  If any doubt about the morphology of the polyp, the patient will be excluded from the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Westmead Hospital</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>August 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Sydney Local Health District</investigator_affiliation>
    <investigator_full_name>Professor Michael Bourke</investigator_full_name>
    <investigator_title>Clinical Professor of Medicine and Director of Endoscopy</investigator_title>
  </responsible_party>
  <keyword>adenoma</keyword>
  <keyword>colorectal cancer</keyword>
  <keyword>polypectomy</keyword>
  <keyword>colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02967107
org study id: HREC/15/WMEAD/507
nct id: NCT02967107
lead sponsor: 
has dmc: Yes
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection
Colorectal cancer (CRC) is the third most common cancer and it remains the second most
      commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence
      and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has
      proven to be effective in reducing mortality and morbidity from CRC and has become common
      practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy)
      occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete
      adenoma resection.

      The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor
      lesions are thought to be a major contributor to the relative failure of colonoscopy in the
      prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the
      period after complete colonoscopy and prior to surveillance, termed 'interval' cancer.

      In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to
      be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of
      SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas,
      and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have
      indistinct margins, and smaller lesions may prove difficult to entrap with the snare because
      of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an
      endoscopic appearance indistinguishable from conventional adenomas, and the surrounding
      serrated component may be overlooked and incompletely resected if this is not recognized.

      The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes
      with regard to polyp detection rate, complete resection rate (CRR) of polyps, patient
      comfort, safety and cost-efficacy. Although colonoscopy is considered the 'gold standard' for
      detecting and removing polyps, the technique is still imperfect. Questions about best
      practice for polypectomy remain, so optimizing the technique is expected to lead to better
      patient outcomes. The optimal treatment of SSPs should be effective, safe and inexpensive.

      Such lesions can be removed by cold snare polypectomy or by endoscopic mucosal resection.
      Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective
      technique for removal of any small polyps (<10 mm). Because of their physical
      characteristics, use of thin wire snares leads to a fast tissue transection and ability to
      remove SSP relatively swiftly. The size of snares suitable for SSP CSP is approximately 9 mm.
      Thus lesions greater than this size would need to be removed in more than one piece,
      introducing the possibility of incomplete resection. Endoscopic mucosal resection (EMR) is
      well established for laterally spreading colorectal lesions. It involves submucosal injection
      and diathermy assisted snare resection by piecemeal or en-bloc depending on polyp size. En
      bloc resection is possible for lesions up to 20 mm and facilitates histopathological
      evaluation. EMR is more time consuming than CSP and may be associated with diathermy related
      complications such as postpolypectomy bleeding, perforation and pain. The most efficient and
      safe method of removal of SSP has not been established.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
time frame: 4-6 months
measure: Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
time frame: 2 weeks
measure: Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
time frame: 2 weeks
measure: Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
time frame: 2 weeks
description: Pain after EMR
arm group label: Cold snare polypectomy
arm group type: Active Comparator
description: Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
arm group label: Endoscopic mucosal resection
arm group type: Active Comparator
description: Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
intervention type: Procedure
intervention name: Cold snare polypectomy
description: Use of a polypectomy snare closed over a polyp without electrocautery
arm group label: Cold snare polypectomy
other name: CSP
intervention type: Procedure
intervention name: Endoscopic mucosal resection
description: Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
arm group label: Endoscopic mucosal resection
other name: EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Western Sydney Local Health District
investigator full name: Professor Michael Bourke
investigator title: Clinical Professor of Medicine and Director of Endoscopy
mesh term: Colorectal Neoplasms
mesh term: Adenoma
sharing ipd: Undecided