<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/NCT03006263</url>
  </required_header>
  <id_info>
    <org_study_id>2016YF021-02</org_study_id>
    <nct_id>NCT03006263</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer</brief_title>
  <official_title>Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore clinical outcomes of totally laparoscopic versus&#xD;
      laparoscopy assisted total gastrectomy for gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>overall postoperative morbidity rates</measure>
    <time_frame>30 days</time_frame>
    <description>Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival rate</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease free survival rate</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year recurrence pattern</measure>
    <time_frame>36 months</time_frame>
    <description>Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative morbidity rates</measure>
    <time_frame>1 day</time_frame>
    <description>The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first ambulation</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first ambulation in hours is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first flatus</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first flatus in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first liquid diet</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first liquid diet in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first soft diet</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first soft diet in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of postoperative hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>30 days</time_frame>
    <description>Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of weight</measure>
    <time_frame>3, 6, 9 and 12 months</time_frame>
    <description>The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of cholesterol</measure>
    <time_frame>3, 6, 9 and 12 months</time_frame>
    <description>The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The results of endoscopy</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of body temperature</measure>
    <time_frame>8 days</time_frame>
    <description>The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of white blood cell count</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of hemoglobin</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of C-reactive protein</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>Totally Laparoscopic Total Gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopy Assisted Total Gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Totally Laparoscopic Total Gastrectomy</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.</description>
    <arm_group_label>Totally Laparoscopic Total Gastrectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopy Assisted Total Gastrectomy</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.</description>
    <arm_group_label>Laparoscopy Assisted Total Gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 to 75 years old&#xD;
&#xD;
          2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or&#xD;
             poorly differentiated) confirmed pathologically by endoscopic biopsy&#xD;
&#xD;
          3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative&#xD;
             evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging&#xD;
             Manual Seventh Edition）&#xD;
&#xD;
          4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby&#xD;
             in the preoperative examinations&#xD;
&#xD;
          5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale&#xD;
&#xD;
          6. ASA (American Society of Anesthesiology) class I to III&#xD;
&#xD;
          7. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and lactating women&#xD;
&#xD;
          2. Suffering from severe mental disorder&#xD;
&#xD;
          3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)&#xD;
&#xD;
          4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal&#xD;
             Dissection/Endoscopic Mucosal Resection )for gastric cancer)&#xD;
&#xD;
          5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative&#xD;
             imaging including enlarged or bulky No.10 lymph node&#xD;
&#xD;
          6. History of other malignant disease within the past 5 years&#xD;
&#xD;
          7. History of previous neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
          8. History of unstable angina or myocardial infarction within the past 6 months&#xD;
&#xD;
          9. History of cerebrovascular accident within the past 6 months&#xD;
&#xD;
         10. History of continuous systematic administration of corticosteroids within 1 month&#xD;
&#xD;
         11. Requirement of simultaneous surgery for other disease&#xD;
&#xD;
         12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by&#xD;
             gastric cancer&#xD;
&#xD;
         13. FEV1&lt;50% of the predicted values&#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>Changming Huang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Medical University Union Hospital,China</affiliation>
  </overall_official>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Medical University</investigator_affiliation>
    <investigator_full_name>Chang-Ming Huang, Prof.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Stomach Neoplasms</keyword>
  <keyword>Totally Laparoscopic Total Gastrectomy</keyword>
  <keyword>Laparoscopy Assisted Total Gastrectomy</keyword>
  <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/NCT03006263
org study id: 2016YF021-02
nct id: NCT03006263
lead sponsor: 
has dmc: Yes
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus
      laparoscopy assisted total gastrectomy for gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall postoperative morbidity rates
time frame: 30 days
description: Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
measure: 3-year overall survival rate
time frame: 36 months
measure: 3-year disease free survival rate
time frame: 36 months
measure: 3-year recurrence pattern
time frame: 36 months
description: Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
measure: Intraoperative morbidity rates
time frame: 1 day
description: The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
measure: Time to first ambulation
time frame: 30 days
description: Time to first ambulation in hours is used to assess the postoperative recovery course.
measure: Time to first flatus
time frame: 30 days
description: Time to first flatus in days is used to assess the postoperative recovery course.
measure: Time to first liquid diet
time frame: 30 days
description: Time to first liquid diet in days is used to assess the postoperative recovery course.
measure: Time to first soft diet
time frame: 30 days
description: Time to first soft diet in days is used to assess the postoperative recovery course.
measure: Duration of postoperative hospital stay
time frame: 30 days
description: Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
measure: Postoperative pain
time frame: 30 days
description: Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
measure: The variation of weight
time frame: 3, 6, 9 and 12 months
description: The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
measure: The variation of cholesterol
time frame: 3, 6, 9 and 12 months
description: The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
measure: The results of endoscopy
time frame: 3 and 12 months
description: The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
measure: The variation of body temperature
time frame: 8 days
description: The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
measure: The variation of white blood cell count
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: The variation of hemoglobin
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: The variation of C-reactive protein
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
arm group label: Totally Laparoscopic Total Gastrectomy
arm group type: Experimental
description: Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.
arm group label: Laparoscopy Assisted Total Gastrectomy
arm group type: Experimental
description: Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
intervention type: Procedure
intervention name: Totally Laparoscopic Total Gastrectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
arm group label: Totally Laparoscopic Total Gastrectomy
intervention type: Procedure
intervention name: Laparoscopy Assisted Total Gastrectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
arm group label: Laparoscopy Assisted Total Gastrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Changming Huang, Professor
role: Principal Investigator
affiliation: Fujian Medical University Union Hospital,China
responsible party type: Principal Investigator
investigator affiliation: Fujian Medical University
investigator full name: Chang-Ming Huang, Prof.
investigator title: Professor
mesh term: Stomach Neoplasms
sharing ipd: No