<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/NCT03021135</url>
  </required_header>
  <id_info>
    <org_study_id>NP 941/16</org_study_id>
    <nct_id>NCT03021135</nct_id>
  </id_info>
  <brief_title>Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions</brief_title>
  <official_title>Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, comparative and prospective study between Conventional Endoscopic Mucosal&#xD;
      Resection for the removal of flat or sessile colorectal lesions without previous attempt to&#xD;
      resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer&#xD;
      do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the&#xD;
      University of São Paulo. The clinical study was performed in accordance to the Declaration of&#xD;
      Helsinki.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2018</start_date>
  <completion_date type="Actual">January 19, 2022</completion_date>
  <primary_completion_date type="Actual">January 19, 2022</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>Technical success rate</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety (incidence of complications);</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local recurrence.</measure>
    <time_frame>Four years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resection rate en bloc</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of resection</measure>
    <time_frame>Three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sydney resection ratio (characterized by the following equation - lesion size in millimeters</measure>
    <time_frame>Three years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Adenoma</condition>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Conventional Mucosal Resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>C-EMR will be made with saline injection with the indigo carmine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Underwater Mucosal Resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UW-EMR will be made after the complete filling of lumen with water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Endoscopic Mucosal Resection</intervention_name>
    <description>Conventional Endoscopic Mucosal Resection</description>
    <arm_group_label>Conventional Mucosal Resection</arm_group_label>
    <other_name>EMR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Underwater Endoscopic Mucosal Resection</intervention_name>
    <description>Underwater Endoscopic Mucosal Resection</description>
    <arm_group_label>Underwater Mucosal Resection</arm_group_label>
    <other_name>U-EMR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age &gt;18 years with sessile or flat Colorectal Lesions (measuring between 10&#xD;
             and 40mm), who consent to this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to participate in the study.&#xD;
&#xD;
          -  Patients with pedunculated, depressed or mixed lesions.&#xD;
&#xD;
          -  Patients with lesions smaller than 10 mm or larger than 40 mm.&#xD;
&#xD;
          -  Patients with lesions that are inflammatory, neuroendocrine or stromal at the&#xD;
             pathology.&#xD;
&#xD;
          -  Patients with lesions that were submitted to prior attempt to endoscopic resection.&#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>Luciano Lenz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute of the state of São Paulo (ICESP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://doi.org/10.1016/j.gie.2022.10.033</url>
    <description>Results</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03021135
org study id: NP 941/16
nct id: NCT03021135
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Randomized, comparative and prospective study between Conventional Endoscopic Mucosal
      Resection for the removal of flat or sessile colorectal lesions without previous attempt to
      resection.
This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer
      do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the
      University of São Paulo. The clinical study was performed in accordance to the Declaration of
      Helsinki.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success rate
time frame: three years
measure: Safety (incidence of complications);
time frame: three years
measure: Local recurrence.
time frame: Four years
measure: Resection rate en bloc
time frame: three years
measure: Time of resection
time frame: Three years
measure: Sydney resection ratio (characterized by the following equation - lesion size in millimeters
time frame: Three years
arm group label: Conventional Mucosal Resection
arm group type: Active Comparator
description: C-EMR will be made with saline injection with the indigo carmine.
arm group label: Underwater Mucosal Resection
arm group type: Experimental
description: UW-EMR will be made after the complete filling of lumen with water.
intervention type: Procedure
intervention name: Conventional Endoscopic Mucosal Resection
description: Conventional Endoscopic Mucosal Resection
arm group label: Conventional Mucosal Resection
other name: EMR
intervention type: Procedure
intervention name: Underwater Endoscopic Mucosal Resection
description: Underwater Endoscopic Mucosal Resection
arm group label: Underwater Mucosal Resection
other name: U-EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luciano Lenz, PhD
role: Principal Investigator
affiliation: Cancer Institute of the state of São Paulo (ICESP)
facility: 
country: Brazil
url: http://doi.org/10.1016/j.gie.2022.10.033
description: Results
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Colorectal Neoplasms
sharing ipd: No