xml: <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/NCT06033482</url>
    </required_header>
    <id_info>
      <org_study_id>E20230548</org_study_id>
      <nct_id>NCT06033482</nct_id>
    </id_info>
    <brief_title>The Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer</brief_title>
    <official_title>A Single Center, Prospective Study on the Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Cancer Institute and Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to evaluate the reasonable range of No.12a lymph node&#xD;
        dissection of locally advanced gastric cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The lymph node metastasis rates in No.12aa and No.12av groups.</measure>
      <time_frame>100 cases enrolled within 1 year</time_frame>
      <description>Observation of lymph node metastasis in different No.12a subgroups12 years</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Gastric Cancer</condition>
    <condition>No.12a Lymph Node Dissection</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>The reasonable range of No.12a lymph node dissection</intervention_name>
      <description>The lymph node overlying the proper hepatic artery is defined as No.12aa. The lymph node overlying the left side of the portal vein is defined as No.12av. Observation of lymph node metastasis rates in two groups.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          100 patients with advanced gastric cancer，underwent radical laparoscopic distal&#xD;
          gastrectomy. Observation of lymph node metastasis in different No.12a subgroups.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 and ≤ 75 years of age; Preoperative gastric cancer patients with pathologically&#xD;
               confirmed; Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph&#xD;
               node≥16); Willing and able to comply with the program during the study period;&#xD;
               Physical condition and organ function allows to tolerable abdominal surgery; Written&#xD;
               informed consent provided; Under radical laparoscopic distal subtotal gastrectomy With&#xD;
               more than a 6-month life expectancy; No other serious concomitant diseases; Sufficient&#xD;
               organ functions; No previous history of chemotherapy or radiotherapy; Clinical stage:&#xD;
               T2-4aNxM0; Karnofsky performance status (KPS)&gt;60; Eastern Cooperative Oncology Group&#xD;
               Performance Status (ECOG): 0-1.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breast feeding; Patients with Serious liver disease (such as cirrhosis,&#xD;
               etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and&#xD;
               other chronic systemic diseases, heart disease with Clinical symptoms, such as&#xD;
               congestive heart failure, coronary heart disease symptoms, drug is difficult to&#xD;
               control arrhythmia, hypertension, or six months had a myocardial infarction attack, or&#xD;
               cardiac insufficiency; Organ transplantation patients need immunosuppressive therapy;&#xD;
               Severe recurrent infections were not controlled or with other serious concomitant&#xD;
               diseases; Patients got other primary malignant tumors (except curable skin basal cell&#xD;
               carcinoma and cervical cancer in situ) except gastric cancer within 5 years;&#xD;
               Psychiatric disease which require treatment; Have the history of organ&#xD;
               transplantation; Within 6 months before study starts and in the process of this study,&#xD;
               patients participate in other clinical researches.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bin Ke, MD</last_name>
      <role>Study Director</role>
      <affiliation>Department of Gastric cancer, Tianjin Medical University Cancer Institute &amp; Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Peng Ru Zhang, MD</last_name>
      <role>Study Director</role>
      <affiliation>Department of Gastric cancer, Tianjin Medical University Cancer Institute &amp; Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bin Ke, MD</last_name>
      <phone>+86 022-23340123-1061</phone>
      <email>binke@tmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Gastric cancer, Tianjin Medical University Cancer Institute &amp; Hospital,</name>
        <address>
          <city>Tianjin</city>
          <state>None Selected</state>
          <zip>300060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bin Ke, md</last_name>
        <email>binke@tmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>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>
  
  
text: 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/NCT06033482
  org study id: E20230548
  nct id: NCT06033482
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this study is to evaluate the reasonable range of No.12a lymph node
        dissection of locally advanced gastric cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: The lymph node metastasis rates in No.12aa and No.12av groups.
  time frame: 100 cases enrolled within 1 year
  description: Observation of lymph node metastasis in different No.12a subgroups12 years
  intervention type: Procedure
  intervention name: The reasonable range of No.12a lymph node dissection
  description: The lymph node overlying the proper hepatic artery is defined as No.12aa. The lymph node overlying the left side of the portal vein is defined as No.12av. Observation of lymph node metastasis rates in two groups.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Bin Ke, MD
  role: Study Director
  affiliation: Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital
  last name: Peng Ru Zhang, MD
  role: Study Director
  affiliation: Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital
  last name: Bin Ke, MD
  phone: +86 022-23340123-1061
  email: binke@tmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  sharing ipd: No