<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/NCT02245971</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0380</org_study_id>
    <nct_id>NCT02245971</nct_id>
  </id_info>
  <brief_title>A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc&#xD;
      resection of superficial tumors in the gastrointestinal tract. ESD, however, is a&#xD;
      time-consuming procedure that requires a high level of endoscopic skill to achieve a&#xD;
      desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of&#xD;
      lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent&#xD;
      position, irrigated water and blood may prevent visual field of ESD.&#xD;
&#xD;
      Generally, whole precutting around the lesion during the ESD is performed prior to&#xD;
      dissection. However, it is expected that partial precutting method for the lesion located in&#xD;
      the antrum of the lesser curvature may improve the visibility of ESD because it can help us&#xD;
      the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time&#xD;
      of ESD for the lesion located in the antrum of the lesser curvature according to the&#xD;
      precutting methods (whole precutting vs. partial precutting).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The investigators decided to terminate the study early because there were no patient candidates&#xD;
    available for registration in the center.&#xD;
  </why_stopped>
  <start_date type="Actual">July 26, 2013</start_date>
  <completion_date type="Actual">August 12, 2014</completion_date>
  <primary_completion_date type="Actual">August 12, 2014</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>Procedure time</measure>
    <time_frame>Within 5 mins after the procedure</time_frame>
    <description>Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>En bloc resection rate</measure>
    <time_frame>Within 7 days after the procedure</time_frame>
    <description>En bloc resection rate according to the precutting methods.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>complete resection rate</measure>
    <time_frame>Within 7 days after the procedure</time_frame>
    <description>complete resection rate according to the precutting methods.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastric Adenoma and Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Whole precutting group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial precutting group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial precutting</intervention_name>
    <description>Partial precutting will be performed prior to dissection during the ESD.</description>
    <arm_group_label>Partial precutting group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whole precutting</intervention_name>
    <description>Whole precutting will be performed prior to dissection during the ESD.</description>
    <arm_group_label>Whole precutting group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 19 years old&#xD;
&#xD;
          2. Patients with gastric adenoma or early gastric cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who has undergone subtotal gastrectomy&#xD;
&#xD;
          2. Patients who has undergone gastrostomy&#xD;
&#xD;
          3. Patients with local recurred gastric adenoma or early gastric cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sevrance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</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>
  </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/NCT02245971
org study id: 4-2014-0380
nct id: NCT02245971
lead sponsor: 
has dmc: No
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc
      resection of superficial tumors in the gastrointestinal tract. ESD, however, is a
      time-consuming procedure that requires a high level of endoscopic skill to achieve a
      desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of
      lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent
      position, irrigated water and blood may prevent visual field of ESD.

      Generally, whole precutting around the lesion during the ESD is performed prior to
      dissection. However, it is expected that partial precutting method for the lesion located in
      the antrum of the lesser curvature may improve the visibility of ESD because it can help us
      the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time
      of ESD for the lesion located in the antrum of the lesser curvature according to the
      precutting methods (whole precutting vs. partial precutting).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedure time
time frame: Within 5 mins after the procedure
description: Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.
measure: En bloc resection rate
time frame: Within 7 days after the procedure
description: En bloc resection rate according to the precutting methods.
measure: complete resection rate
time frame: Within 7 days after the procedure
description: complete resection rate according to the precutting methods.
arm group label: Whole precutting group
arm group type: Active Comparator
arm group label: Partial precutting group
arm group type: Active Comparator
intervention type: Procedure
intervention name: Partial precutting
description: Partial precutting will be performed prior to dissection during the ESD.
arm group label: Partial precutting group
intervention type: Procedure
intervention name: Whole precutting
description: Whole precutting will be performed prior to dissection during the ESD.
arm group label: Whole precutting group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Adenoma