<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/NCT02219854</url>
  </required_header>
  <id_info>
    <org_study_id>LASS-01</org_study_id>
    <nct_id>NCT02219854</nct_id>
  </id_info>
  <brief_title>Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric&#xD;
      cancer is popular in East Asian countries. However, the long-term follow-up outcome based on&#xD;
      randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic&#xD;
      distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe&#xD;
      procedure by experienced surgeons in high-volume specialized hospitals. However, the&#xD;
      application of it is still limited because of lack of solid evidence on the oncologic&#xD;
      efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is&#xD;
      estimated up to 80 percent of all gastric cancer cases in China. Before the clinical&#xD;
      application of laparoscopic procedure for the treatment with curative intent to advanced&#xD;
      gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy&#xD;
      must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and&#xD;
      open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer&#xD;
      based on a well designed RCT is needed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>3-year disease free survival rate</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recovery situation</measure>
    <time_frame>10 days</time_frame>
    <description>Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">178</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic gastrectomy</intervention_name>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open gastrectomy</intervention_name>
    <arm_group_label>Open gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular,&#xD;
             mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by&#xD;
             endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC&#xD;
             Cancer Staging Manual Seventh Edition Expected curative resection through distal&#xD;
             subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG&#xD;
             (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology)&#xD;
             score class I, II, or III Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women during pregnancy or breast-feeding Severe mental disorder History of previous&#xD;
             upper abdominal surgery (except laparoscopic cholecystectomy) History of previous&#xD;
             gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged&#xD;
             or bulky regional lymph node diameter over 3cm by preoperative imaging History of&#xD;
             other malignant disease within past five years History of previous neoadjuvant&#xD;
             chemotherapy or radiotherapy History of unstable angina or myocardial infarction&#xD;
             within past six months History of cerebrovascular accident within past six months&#xD;
             History of continuous systematic administration of corticosteroids within one month&#xD;
             Requirement of simultaneous surgery for other disease Emergency surgery due to&#xD;
             complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1&lt;50%&#xD;
             of predicted values&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongbo Wei, M.D. Ph.D.</last_name>
    <phone>+86-189-2210-2969</phone>
    <email>drweihb@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongbo Wei, M.D., Ph.D.</last_name>
      <phone>8613760660785</phone>
    </contact>
    <investigator>
      <last_name>Hongbo Wei, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>March 4, 2019</last_update_submitted>
  <last_update_submitted_qc>March 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Hongbo Wei</investigator_full_name>
    <investigator_title>Chief of surgery</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>
  <!-- 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/NCT02219854
org study id: LASS-01
nct id: NCT02219854
lead sponsor: 
has dmc: Yes
Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric
      cancer is popular in East Asian countries. However, the long-term follow-up outcome based on
      randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic
      distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe
      procedure by experienced surgeons in high-volume specialized hospitals. However, the
      application of it is still limited because of lack of solid evidence on the oncologic
      efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is
      estimated up to 80 percent of all gastric cancer cases in China. Before the clinical
      application of laparoscopic procedure for the treatment with curative intent to advanced
      gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy
      must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and
      open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer
      based on a well designed RCT is needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year disease free survival rate
time frame: 36 months
measure: Morbidity
time frame: 30 days
measure: 3-year overall survival rate
time frame: 36 months
measure: 3-year recurrence pattern
time frame: 36 months
measure: Mortality
time frame: 30 days
measure: Morbidity
time frame: 36 months
measure: Mortality
time frame: 36 months
measure: Postoperative recovery situation
time frame: 10 days
description: Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.
arm group label: Laparoscopic gastrectomy
arm group type: Experimental
description: Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
arm group label: Open gastrectomy
arm group type: Active Comparator
description: Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
intervention type: Procedure
intervention name: Laparoscopic gastrectomy
arm group label: Laparoscopic gastrectomy
intervention type: Procedure
intervention name: Open gastrectomy
arm group label: Open gastrectomy
criteria: 
gender: All
minimum age: 19 Years
maximum age: 74 Years
healthy volunteers: No
last name: Hongbo Wei, M.D. Ph.D.
phone: +86-189-2210-2969
email: drweihb@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Hongbo Wei
investigator title: Chief of surgery
mesh term: Stomach Neoplasms