<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/NCT02216110</url>
  </required_header>
  <id_info>
    <org_study_id>SCHDDC-2014-01</org_study_id>
    <nct_id>NCT02216110</nct_id>
  </id_info>
  <brief_title>Endoscopic Submucosal Dissection Versus Gastrectomy</brief_title>
  <official_title>Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic&#xD;
      submucosal dissection (ESD) has been accepted as standard treatment in selected patients with&#xD;
      negligible risk of lymph node metastasis. However, there are limited data regarding the&#xD;
      long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall&#xD;
      survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea,&#xD;
      the detection rate of EGC has increased with mass screening for the prevention of gastric&#xD;
      cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional&#xD;
      lymph node metastasis. The presence of lymph node metastasis has been reported to range from&#xD;
      2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as&#xD;
      the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year&#xD;
      survival rate above 90%.&#xD;
&#xD;
      In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the&#xD;
      basis of large scale retrospective data. Thereafter, the result was adopted as expanded&#xD;
      criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along&#xD;
      the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal&#xD;
      resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor&#xD;
      recurrence rate.&#xD;
&#xD;
      Although curative resection is pathologically achieved by ESD, post-resection surveillance is&#xD;
      needed to confirm the presence of nodal metastasis. Recently, several studies reported that&#xD;
      5-year overall and disease-specific survival rate were highly favorable in EGC patients who&#xD;
      underwent curative ESD. However, there is no comparative study about long-term outcomes after&#xD;
      ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor&#xD;
      recurrence, development of metachronous cancers between ESD and surgery groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2003</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient's death</measure>
    <time_frame>up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor recurrence</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of metachronous cancers</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Surgery group</arm_group_label>
    <description>Patients who underwent surgery as treatment of early gastric cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESD group</arm_group_label>
    <description>Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection</description>
    <arm_group_label>Surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with early gastric cancer were treated by surgery or ESD at a single,&#xD;
        tertiary-care, academic medical center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  differentiated type mucosal cancer without ulceration, regardless of tumor size&#xD;
&#xD;
          -  differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter&#xD;
&#xD;
          -  superficial (SM1 &lt; 500 μm) submucosal cancer ≤ 3 cm in diameter&#xD;
&#xD;
          -  undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  early gastric cancer in a remnant stomach&#xD;
&#xD;
          -  gastrectomy due to metachronous lesions during follow-up period&#xD;
&#xD;
          -  post-ESD additional surgery due to high risk of lymph node metastasis or the&#xD;
             possibility of residual tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun-Hyung Cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soonchunhyang University Hospital, Seoul, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital</name>
      <address>
        <city>SeouL</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 19, 2015</last_update_submitted>
  <last_update_submitted_qc>May 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Jun-Hyung Cho</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Endoscopic submucosal dissection</keyword>
  <keyword>Gastrectomy</keyword>
  <keyword>Survival</keyword>
  <keyword>Outcome</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/NCT02216110
org study id: SCHDDC-2014-01
nct id: NCT02216110
lead sponsor: 
has dmc: Yes
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic
      submucosal dissection (ESD) has been accepted as standard treatment in selected patients with
      negligible risk of lymph node metastasis. However, there are limited data regarding the
      long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall
      survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea,
      the detection rate of EGC has increased with mass screening for the prevention of gastric
      cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional
      lymph node metastasis. The presence of lymph node metastasis has been reported to range from
      2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as
      the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year
      survival rate above 90%.

      In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the
      basis of large scale retrospective data. Thereafter, the result was adopted as expanded
      criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along
      the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal
      resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor
      recurrence rate.

      Although curative resection is pathologically achieved by ESD, post-resection surveillance is
      needed to confirm the presence of nodal metastasis. Recently, several studies reported that
      5-year overall and disease-specific survival rate were highly favorable in EGC patients who
      underwent curative ESD. However, there is no comparative study about long-term outcomes after
      ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor
      recurrence, development of metachronous cancers between ESD and surgery groups.
observational model: Cohort
time perspective: Retrospective
measure: Patient's death
time frame: up to 5 years
measure: Tumor recurrence
time frame: up to 5 years
measure: Development of metachronous cancers
time frame: up to 5 years
arm group label: Surgery group
description: Patients who underwent surgery as treatment of early gastric cancer
arm group label: ESD group
description: Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery
intervention type: Procedure
intervention name: Surgery
description: Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
arm group label: Surgery group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jun-Hyung Cho, M.D.
role: Principal Investigator
affiliation: Soonchunhyang University Hospital, Seoul, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Jun-Hyung Cho
investigator title: Assistant Professor
mesh term: Stomach Neoplasms