<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/NCT02980861</url>
  </required_header>
  <id_info>
    <org_study_id>Z161100000516237</org_study_id>
    <nct_id>NCT02980861</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection</brief_title>
  <official_title>Laparoscopic Versus Open 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>
      Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The&#xD;
      application of minimally invasive surgery for advanced gastric cancer is gaining popularity.&#xD;
      The investigators aim to compare the safety and feasibility of LTG and OTG for advanced&#xD;
      proximal gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients&#xD;
      with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic&#xD;
      hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however,&#xD;
      complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels&#xD;
      and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently,&#xD;
      the application of minimally invasive surgery for advanced gastric cancer is gaining&#xD;
      popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy&#xD;
      was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph&#xD;
      node dissection were mainly challenging manipulations for laparoscopic surgeons.&#xD;
      Therefore,the investigators aim to investigate the safety and feasibility of LTG with&#xD;
      spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer&#xD;
      and compare the early results of this procedure with open total gastrectomy (OTG).&#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">June 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 group Splenic Hilum (No.10) 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative blood loss</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of splenic hilum lymph nodes dissection</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of total lymph nodes harvested</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative recovery course</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course</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>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>It will be assessed by questionnaire (WHO quality of life-100)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Laparoscopic total gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open total gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic total gastrectomy</intervention_name>
    <description>When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
    <arm_group_label>Laparoscopic total gastrectomy</arm_group_label>
    <other_name>LTG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open total gastrectomy</intervention_name>
    <description>When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.</description>
    <arm_group_label>Open total gastrectomy</arm_group_label>
    <other_name>OTG</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 American Joint Committee On&#xD;
             Cancer (AJCC) Cancer Staging Manual, 7th 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>010-66938128</phone>
  </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, Master</last_name>
      <phone>86-13801290395</phone>
      <email>chenlinbj@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.</citation>
    <PMID>26940944</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 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>Director</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>Splenic Hilum Lymph Nodes Dissection</keyword>
  <keyword>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/NCT02980861
org study id: Z161100000516237
nct id: NCT02980861
lead sponsor: 
has dmc: Yes
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The
      application of minimally invasive surgery for advanced gastric cancer is gaining popularity.
      The investigators aim to compare the safety and feasibility of LTG and OTG for advanced
      proximal gastric cancer.
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients
      with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic
      hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however,
      complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels
      and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently,
      the application of minimally invasive surgery for advanced gastric cancer is gaining
      popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy
      was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph
      node dissection were mainly challenging manipulations for laparoscopic surgeons.
      Therefore,the investigators aim to investigate the safety and feasibility of LTG with
      spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer
      and compare the early results of this procedure with open total gastrectomy (OTG).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of group Splenic Hilum (No.10) 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
measure: Operative time
time frame: Intraoperative
measure: Operative blood loss
time frame: Intraoperative
measure: Time of splenic hilum lymph nodes dissection
time frame: Intraoperative
measure: Number of total lymph nodes harvested
time frame: 7 days
measure: Post-operative recovery course
time frame: 30 days
description: Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course
measure: 3-year disease free survival rate
time frame: 3 years
measure: 3-year overall survival rate
time frame: 3 years
measure: Quality of life
time frame: 1 year
description: It will be assessed by questionnaire (WHO quality of life-100)
arm group label: Laparoscopic total gastrectomy
arm group type: Experimental
description: Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
arm group label: Open total gastrectomy
arm group type: Active Comparator
description: Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
intervention type: Procedure
intervention name: Laparoscopic total gastrectomy
description: When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
arm group label: Laparoscopic total gastrectomy
other name: LTG
intervention type: Procedure
intervention name: Open total gastrectomy
description: When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
arm group label: Open total gastrectomy
other name: OTG
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: 010-66938128
facility: 
contact: 
country: China
citation: Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
PMID: 26940944
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Lin Chen
investigator title: Director
mesh term: Stomach Neoplasms
sharing ipd: No