<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/NCT02984787</url>
  </required_header>
  <id_info>
    <org_study_id>Experiment20161201</org_study_id>
    <nct_id>NCT02984787</nct_id>
  </id_info>
  <brief_title>3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection</brief_title>
  <official_title>3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will perform a prospective randomized comparison between 3D and 2D&#xD;
      laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric&#xD;
      cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to&#xD;
      evaluate the safety and feasibility for the extensive application of the novel 3D&#xD;
      laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes&#xD;
      harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival&#xD;
      and recurrence rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 3</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>Number of splenic hilum lymph nodes harvested</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early complication rate</measure>
    <time_frame>30 days</time_frame>
    <description>The early complication rate is defined as the event observed during operation and within 30 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Intraoperative</time_frame>
    <description>It will be assessed with the unit of &quot;minute&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative blood loss</measure>
    <time_frame>Intraoperative</time_frame>
    <description>It will be assessed with the unit of &quot;ml&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of splenic hilum lymph nodes dissection</measure>
    <time_frame>Intraoperative</time_frame>
    <description>It will be assessed with the unit of &quot;minute&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of total lymph nodes harvested</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Poster-operative recovery course</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>It will be assessed with questionnaire of &quot;WHO-QOL-100&quot; (WHO was short for world health organization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease free survival rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Splenic Hilum Lymph Nodes Dissection</condition>
  <arm_group>
    <arm_group_label>3D Laparoscopic total gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2D Laparoscopic total gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D Laparoscopic total gastrectomy</intervention_name>
    <description>When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection</description>
    <arm_group_label>3D Laparoscopic total gastrectomy</arm_group_label>
    <other_name>3D-LTG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>2D Laparoscopic total gastrectomy</intervention_name>
    <description>When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection</description>
    <arm_group_label>2D Laparoscopic total gastrectomy</arm_group_label>
    <other_name>2D-LTG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;&#xD;
&#xD;
          2. cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th&#xD;
             Edition.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;&#xD;
&#xD;
          4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;&#xD;
&#xD;
          5. Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breast-feeding women;&#xD;
&#xD;
          2. Severe mental disorder;&#xD;
&#xD;
          3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);&#xD;
&#xD;
          4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal&#xD;
             dissection;&#xD;
&#xD;
          5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative&#xD;
             imaging;&#xD;
&#xD;
          6. Other malignant disease within the past 5 years;&#xD;
&#xD;
          7. Previous neoadjuvant chemotherapy or radiotherapy;&#xD;
&#xD;
          8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);&#xD;
&#xD;
          9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused&#xD;
             by gastric cancer.&#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>Lin Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>the Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongqing Xi, Master</last_name>
    <phone>86-13801290395</phone>
    <email>chenlinbj@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Lin Chen</last_name>
      <phone>86-13801290395</phone>
      <email>chenlinbj@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Lin Chen</investigator_full_name>
    <investigator_title>Deputy Director</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>3D</keyword>
  <keyword>2D</keyword>
  <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/NCT02984787
org study id: Experiment20161201
nct id: NCT02984787
lead sponsor: 
has dmc: Yes
The investigators will perform a prospective randomized comparison between 3D and 2D
      laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.
A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric
      cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to
      evaluate the safety and feasibility for the extensive application of the novel 3D
      laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes
      harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival
      and recurrence rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of splenic hilum lymph nodes harvested
time frame: 7 days
measure: Early complication rate
time frame: 30 days
description: The early complication rate is defined as the event observed during operation and within 30 days after surgery.
measure: Operative time
time frame: Intraoperative
description: It will be assessed with the unit of "minute".
measure: Operative blood loss
time frame: Intraoperative
description: It will be assessed with the unit of "ml".
measure: Time of splenic hilum lymph nodes dissection
time frame: Intraoperative
description: It will be assessed with the unit of "minute"
measure: Number of total lymph nodes harvested
time frame: 7 days
measure: Poster-operative recovery course
time frame: 30 days
description: Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course.
measure: Quality of life
time frame: 1 year
description: It will be assessed with questionnaire of "WHO-QOL-100" (WHO was short for world health organization)
measure: 3-year disease free survival rate
time frame: 3 years
measure: 3-year overall survival rate
time frame: 3 years
arm group label: 3D Laparoscopic total gastrectomy
arm group type: Experimental
description: Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
arm group label: 2D Laparoscopic total gastrectomy
arm group type: Active Comparator
description: Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
intervention type: Procedure
intervention name: 3D Laparoscopic total gastrectomy
description: When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
arm group label: 3D Laparoscopic total gastrectomy
other name: 3D-LTG
intervention type: Procedure
intervention name: 2D Laparoscopic total gastrectomy
description: When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
arm group label: 2D Laparoscopic total gastrectomy
other name: 2D-LTG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lin Chen
role: Principal Investigator
affiliation: the Chinese PLA General Hospital
last name: Hongqing Xi, Master
phone: 86-13801290395
email: chenlinbj@sina.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Lin Chen
investigator title: Deputy Director
sharing ipd: No