<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/NCT02973490</url>
  </required_header>
  <id_info>
    <org_study_id>D2016-11</org_study_id>
    <nct_id>NCT02973490</nct_id>
  </id_info>
  <brief_title>Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor</brief_title>
  <official_title>Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Superiority Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We design the clincal trial to investigate the efficacy of transanal tube drainage in&#xD;
      colorectal ESD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that&#xD;
      enables endoscopists to control the depth and direction of diathermic knife&#xD;
      incisions.Recently, the number of reports in which ESD has been successfully used to treat&#xD;
      colorectal tumors has increased. But the complatios with colorectal ESD were higher than&#xD;
      esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of&#xD;
      transanal tube drainage in colorectal ESD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>postoperative complications</measure>
    <time_frame>30 days post operatively</time_frame>
    <description>bleeding, perforation,coagulation syndrome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Colorectal Tumor</condition>
  <arm_group>
    <arm_group_label>Transanal Tube Drainage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with transanal tube drainage after ESD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Transanal Tube Drainage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients without transanal tube drainage after ESD</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transanal Tube Drainage</intervention_name>
    <description>Using transanal tube drainage after colorectal ESD</description>
    <arm_group_label>Transanal Tube Drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Endoscopy proven colorectal polyp&gt;2cm, LST&gt;3cm, SMTs&lt;2cm Suitable for ESD No other&#xD;
             organic disease of colorectal Removing a single lesion one time Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous&#xD;
             polyposis With previous colorectal surgery Pregnancy or lactation Absolute&#xD;
             contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class &gt;&#xD;
             III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family&#xD;
             members can not understand and accept this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Center, Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xu jianmin</investigator_full_name>
    <investigator_title>Zhongshan Hospital Endoscopy center</investigator_title>
  </responsible_party>
  <keyword>ESD;Transanal Tube Drainage;Colorectal Tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02973490
org study id: D2016-11
nct id: NCT02973490
lead sponsor: 
has dmc: Yes
We design the clincal trial to investigate the efficacy of transanal tube drainage in
      colorectal ESD.
Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that
      enables endoscopists to control the depth and direction of diathermic knife
      incisions.Recently, the number of reports in which ESD has been successfully used to treat
      colorectal tumors has increased. But the complatios with colorectal ESD were higher than
      esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of
      transanal tube drainage in colorectal ESD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative complications
time frame: 30 days post operatively
description: bleeding, perforation,coagulation syndrome
arm group label: Transanal Tube Drainage
arm group type: Experimental
description: patients with transanal tube drainage after ESD
arm group label: Without Transanal Tube Drainage
arm group type: No Intervention
description: patients without transanal tube drainage after ESD
intervention type: Device
intervention name: Transanal Tube Drainage
description: Using transanal tube drainage after colorectal ESD
arm group label: Transanal Tube Drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xu jianmin
investigator title: Zhongshan Hospital Endoscopy center
mesh term: Colorectal Neoplasms
sharing ipd: No