<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/NCT03837301</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2018-0162</org_study_id>
    <nct_id>NCT03837301</nct_id>
  </id_info>
  <brief_title>Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)</brief_title>
  <official_title>Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</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>
      Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric&#xD;
      cancer is less invasive method which can increase quality of life. Current stomach preserving&#xD;
      surgery after sentinel lymph node dissection produce transmural communication and expose the&#xD;
      tumor to the peritoneum during operation. An endoscopic full-thickness resection method with&#xD;
      a simple suturing technique that does not expose the gastric mucosa to the peritoneum&#xD;
      (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently&#xD;
      developed.&#xD;
&#xD;
      This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation&#xD;
      in early gastric cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 12, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete resection rate (%) of tumor</measure>
    <time_frame>2 weeks</time_frame>
    <description>the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>NESS-EFTR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NESS-EFTR with sentinel lymph node navigation</intervention_name>
    <description>Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients</description>
    <arm_group_label>NESS-EFTR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single lesion of adenocarcinoma in preoperative endoscopic biopsy&#xD;
&#xD;
          -  clinical stage T1N0 in the preoperative evaluation of endoscopy and computed&#xD;
             tomography&#xD;
&#xD;
          -  tumor size: less than 3cm&#xD;
&#xD;
          -  location: 3cm far from the pylorus or cardia&#xD;
&#xD;
          -  aged 20 to 80&#xD;
&#xD;
          -  ECOG 0 or 1&#xD;
&#xD;
          -  patient who signed the agreement&#xD;
&#xD;
          -  patient who is suspected to underwent laparoscopy assisted gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absolute indication of endoscopic submucosal resection&#xD;
&#xD;
          -  inoperable due to poor cardiac, pulmonary function&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  having allergic reaction, previous upper abdominal surgery except laparoscopic&#xD;
             cholecystectomy, previous radiation therapy to upper abdomen&#xD;
&#xD;
          -  diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and&#xD;
             thyroid cancer&#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>Chan G Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chan G Kim, M.D.</last_name>
    <phone>+82319201120</phone>
    <email>glse@ncc.re.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chan G Kim, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Chan Gyoo Kim</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT03837301
org study id: NCC2018-0162
nct id: NCT03837301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric
      cancer is less invasive method which can increase quality of life. Current stomach preserving
      surgery after sentinel lymph node dissection produce transmural communication and expose the
      tumor to the peritoneum during operation. An endoscopic full-thickness resection method with
      a simple suturing technique that does not expose the gastric mucosa to the peritoneum
      (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently
      developed.

      This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation
      in early gastric cancer patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete resection rate (%) of tumor
time frame: 2 weeks
description: the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.
arm group label: NESS-EFTR
arm group type: Experimental
description: Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)
intervention type: Procedure
intervention name: NESS-EFTR with sentinel lymph node navigation
description: Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients
arm group label: NESS-EFTR
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chan G Kim, M.D.
role: Principal Investigator
affiliation: National Cancer Center
last name: Chan G Kim, M.D.
phone: +82319201120
email: glse@ncc.re.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Chan Gyoo Kim
investigator title: M.D.
mesh term: Stomach Neoplasms
sharing ipd: No