<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/NCT02189226</url>
  </required_header>
  <id_info>
    <org_study_id>1-2013-0009</org_study_id>
    <nct_id>NCT02189226</nct_id>
  </id_info>
  <brief_title>Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection</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>
      The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser&#xD;
      endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of&#xD;
      early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">January 20, 2015</completion_date>
  <primary_completion_date type="Actual">January 20, 2015</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>Complete resection rate</measure>
    <time_frame>One week after ESD</time_frame>
    <description>Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Horizontal cut end-positive</measure>
    <time_frame>Within the first 30 days after ESD</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vertical cut end-positive</measure>
    <time_frame>Within the first 30 days after ESD</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedure time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>Within the first 30 days after ESD</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>probe-based confocal laser endomicroscopy (pCLE) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>chromoendoscopy (CE) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)</intervention_name>
    <description>Before ESD, the lesion will be observed either by pCLE or by CE to determine proximal and distal margin of the lesion. In the pCLE group, after injection of intravenous fluorescein, the lesion will be observed using a flexible confocal miniprobe. In the CE group, the lesion will be observed conventionally under white light after spraying indigocarmine directly via the forceps channel. Marking dots will be placed on both margins using needle knife. Then several dots will be marked on the surrounding normal mucosa 5 mm from the tumor with Argon plasma coagulation. After injection of saline solution with epinephrine into the submucosa, an initial cut will be made with needle knife outside the line of surrounding marks. An insulation-tipped (IT) knife will be inserted into initial cut, and electrosurgical current will be applied to complete the incision around the tumor. After the circumferential cut, the submucosa will be dissected with the IT knife.</description>
    <arm_group_label>chromoendoscopy (CE) group</arm_group_label>
    <arm_group_label>probe-based confocal laser endomicroscopy (pCLE) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1)&#xD;
             Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with&#xD;
             ulcer, ≤ 3 cm 3) Differentiated minute (&lt;500 μm) submucosal invasive cancer, ≤ 3 cm 4)&#xD;
             Undifferentiated mucosal cancer without ulcer, ≤ 2 cm&#xD;
&#xD;
          -  Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC&#xD;
             and treated by ESD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy : International normalized ratio [INR] &gt; 1.5 or platelet count &lt;50,000&#xD;
             cell/cubic millimeter)&#xD;
&#xD;
          -  Impaired renal function : Cr &gt; 1.2 mg/dL&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  Age &lt; 20 years&#xD;
&#xD;
          -  Allergy to fluorescein dye&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance 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>December 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>probe-based confocal laser endomicroscopy (pCLE), early gastric cancer (EGC), endoscopic submucosal dissection (ESD), margin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</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/NCT02189226
org study id: 1-2013-0009
nct id: NCT02189226
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser
      endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of
      early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete resection rate
time frame: One week after ESD
description: Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.
measure: Horizontal cut end-positive
time frame: Within the first 30 days after ESD
measure: vertical cut end-positive
time frame: Within the first 30 days after ESD
measure: procedure time
time frame: 1 day
measure: adverse event
time frame: Within the first 30 days after ESD
arm group label: probe-based confocal laser endomicroscopy (pCLE) group
arm group type: Experimental
arm group label: chromoendoscopy (CE) group
arm group type: Active Comparator
intervention type: Device
intervention name: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)
description: Before ESD, the lesion will be observed either by pCLE or by CE to determine proximal and distal margin of the lesion. In the pCLE group, after injection of intravenous fluorescein, the lesion will be observed using a flexible confocal miniprobe. In the CE group, the lesion will be observed conventionally under white light after spraying indigocarmine directly via the forceps channel. Marking dots will be placed on both margins using needle knife. Then several dots will be marked on the surrounding normal mucosa 5 mm from the tumor with Argon plasma coagulation. After injection of saline solution with epinephrine into the submucosa, an initial cut will be made with needle knife outside the line of surrounding marks. An insulation-tipped (IT) knife will be inserted into initial cut, and electrosurgical current will be applied to complete the incision around the tumor. After the circumferential cut, the submucosa will be dissected with the IT knife.
arm group label: chromoendoscopy (CE) group
arm group label: probe-based confocal laser endomicroscopy (pCLE) group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stomach Neoplasms