<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/NCT02246153</url>
  </required_header>
  <id_info>
    <org_study_id>NFEC-2014-067</org_study_id>
    <nct_id>NCT02246153</nct_id>
  </id_info>
  <brief_title>Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients</brief_title>
  <official_title>Morbidity and Mortality of Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC)&#xD;
           has been supported by high-quality evidence, and the high-level evidence for advanced&#xD;
           gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG&#xD;
           0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence&#xD;
           of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer&#xD;
           (AGC).&#xD;
&#xD;
        -  China has entered the aging society since 1999. Among the GC patients in China, the&#xD;
           average age is 65 years old, which makes increasing attempts to explore laparoscopic&#xD;
           techniques in the treatment of elderly patients.&#xD;
&#xD;
        -  Nowadays, a considerable proportion of elderly patients suffer from multiple diseases,&#xD;
           such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative&#xD;
           and postoperative complications can not be ignored. Unfortunately, there are rare&#xD;
           studies specializing into the LAG for the GC patients of &gt; 65 years old.&#xD;
&#xD;
        -  Accordingly, the comparison of intraoperative and postoperative complications between&#xD;
           laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with&#xD;
           gastric cancer based on a randomized controlled trial is warranted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Postoperative complication rate</measure>
    <time_frame>30 days</time_frame>
    <description>30 day morbidity and mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pulmonary complications</measure>
    <time_frame>30 days</time_frame>
    <description>Pulmonary complications after operation within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recovery index</measure>
    <time_frame>7 days</time_frame>
    <description>participants will be followed for the duration of hospital stay after operation, an expected average of 7 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">202</enrollment>
  <condition>Complications</condition>
  <arm_group>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopy-assisted distal 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 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>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.&#xD;
The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.</description>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
    <other_name>LDG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open gastrectomy</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.&#xD;
The type of reconstruction will be selected according to the surgeon's experience.</description>
    <arm_group_label>Open gastrectomy</arm_group_label>
    <other_name>ODG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 65 years&#xD;
&#xD;
          -  Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or&#xD;
             poorly differentiated) confirmed pathologically by endoscopic biopsy&#xD;
&#xD;
          -  cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging&#xD;
             Manual Seventh Edition&#xD;
&#xD;
          -  Expected curative resection through distal subtotal gastrectomy with D2&#xD;
             lymphadenectomy&#xD;
&#xD;
          -  Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale&#xD;
&#xD;
          -  ASA (American Society of Anesthesiology) score class I, II, or III&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental disorder&#xD;
&#xD;
          -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)&#xD;
&#xD;
          -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal&#xD;
             dissection&#xD;
&#xD;
          -  Exclude the early gastric cancer feasible for ESD&#xD;
&#xD;
          -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging&#xD;
&#xD;
          -  History of other malignant disease within past five years&#xD;
&#xD;
          -  History of previous neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
          -  History of unstable angina or myocardial infarction within past six months&#xD;
&#xD;
          -  History of cerebrovascular accident within past six months&#xD;
&#xD;
          -  History of continuous systematic administration of corticosteroids within one month&#xD;
&#xD;
          -  Requirement of simultaneous surgery for other disease&#xD;
&#xD;
          -  Emergency surgery due to complication (bleeding, obstruction or perforation) caused by&#xD;
             gastric cancer&#xD;
&#xD;
          -  FEV1&lt;50% of predicted values&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guoxin Li, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guoxin Li, M.D., Ph.D.</last_name>
    <phone>+86-138-0277-1450</phone>
    <email>gzliguoxin@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hao Liu, M.D., PhD</last_name>
    <phone>+86-138-2215-8578</phone>
    <email>liuhaofbi@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guoxin Li, M.D., Ph.D.</last_name>
      <phone>+86-138-0277-1450</phone>
      <email>gzliguoxin@163.com</email>
    </contact>
    <investigator>
      <last_name>Guoxin Li, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jiang Yu, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yanfeng Hu, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tingyu Mou, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hao Liu, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.fimmu.com/index_com.html</url>
    <description>Southern Medical University, China</description>
  </link>
  <link>
    <url>http://www.nfyy.com/</url>
    <description>Nanfang Hospital, China</description>
  </link>
  <link>
    <url>http://www.caca.org.cn/</url>
    <description>Chinese Anti-Cancer Association</description>
  </link>
  <reference>
    <citation>Yu J, Hu J, Huang C, Ying M, Peng X, Wei H, Jiang Z, Du X, Liu Z, Liu H, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. The impact of age and comorbidity on postoperative complications in patients with advanced gastric cancer after laparoscopic D2 gastrectomy: results from the Chinese laparoscropic gastrointestinal surgery study (CLASS) group. Eur J Surg Oncol. 2013 Oct;39(10):1144-9. doi: 10.1016/j.ejso.2013.06.021. Epub 2013 Jul 10.</citation>
    <PMID>23850088</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>January 7, 2017</last_update_submitted>
  <last_update_submitted_qc>January 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Guoxin Li</investigator_full_name>
    <investigator_title>M.D.,Ph.D., F.R.C.S.</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic gastrectomy</keyword>
  <keyword>Advanced gastric cancer</keyword>
  <keyword>Elderly patients</keyword>
  <keyword>Morbidity</keyword>
  <keyword>Mortality</keyword>
  <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/NCT02246153
org study id: NFEC-2014-067
nct id: NCT02246153
lead sponsor: 
has dmc: Yes
-  Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC)
           has been supported by high-quality evidence, and the high-level evidence for advanced
           gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG
           0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence
           of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer
           (AGC).

        -  China has entered the aging society since 1999. Among the GC patients in China, the
           average age is 65 years old, which makes increasing attempts to explore laparoscopic
           techniques in the treatment of elderly patients.

        -  Nowadays, a considerable proportion of elderly patients suffer from multiple diseases,
           such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative
           and postoperative complications can not be ignored. Unfortunately, there are rare
           studies specializing into the LAG for the GC patients of > 65 years old.

        -  Accordingly, the comparison of intraoperative and postoperative complications between
           laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with
           gastric cancer based on a randomized controlled trial is warranted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative complication rate
time frame: 30 days
description: 30 day morbidity and mortality
measure: Postoperative pulmonary complications
time frame: 30 days
description: Pulmonary complications after operation within 30 days
measure: Postoperative recovery index
time frame: 7 days
description: participants will be followed for the duration of hospital stay after operation, an expected average of 7 days
arm group label: Laparoscopic gastrectomy
arm group type: Experimental
description: Laparoscopy-assisted distal 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 gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
intervention type: Procedure
intervention name: Laparoscopic gastrectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
arm group label: Laparoscopic gastrectomy
other name: LDG
intervention type: Procedure
intervention name: Open gastrectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
The type of reconstruction will be selected according to the surgeon's experience.
arm group label: Open gastrectomy
other name: ODG
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Guoxin Li, M.D., Ph.D.
role: Principal Investigator
affiliation: Nanfang Hospital, Southern Medical University
last name: Guoxin Li, M.D., Ph.D.
phone: +86-138-0277-1450
email: gzliguoxin@163.com
last name: Hao Liu, M.D., PhD
phone: +86-138-2215-8578
email: liuhaofbi@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
url: http://www.fimmu.com/index_com.html
description: Southern Medical University, China
url: http://www.nfyy.com/
description: Nanfang Hospital, China
url: http://www.caca.org.cn/
description: Chinese Anti-Cancer Association
citation: Yu J, Hu J, Huang C, Ying M, Peng X, Wei H, Jiang Z, Du X, Liu Z, Liu H, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. The impact of age and comorbidity on postoperative complications in patients with advanced gastric cancer after laparoscopic D2 gastrectomy: results from the Chinese laparoscropic gastrointestinal surgery study (CLASS) group. Eur J Surg Oncol. 2013 Oct;39(10):1144-9. doi: 10.1016/j.ejso.2013.06.021. Epub 2013 Jul 10.
PMID: 23850088
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Guoxin Li
investigator title: M.D.,Ph.D., F.R.C.S.
mesh term: Stomach Neoplasms