<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/NCT02969148</url>
  </required_header>
  <id_info>
    <org_study_id>LBDL1</org_study_id>
    <nct_id>NCT02969148</nct_id>
  </id_info>
  <brief_title>Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer</brief_title>
  <acronym>LBDL</acronym>
  <official_title>Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2&#xD;
      lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced&#xD;
      gastric cancer by prospective randomized controlled clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective&#xD;
      randomized controlled trial will be performed in the GI department, Guangdong provincial&#xD;
      hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases&#xD;
      with advanced gastric cancer, will be needed after calculated by the statistics. The 100&#xD;
      cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes&#xD;
      are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years'&#xD;
      and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall&#xD;
      survival（OS）rate, operative time, the total blood loss, the intra-operative complication and&#xD;
      the post-operative complication, the number of lymph nodes dissected, the number of&#xD;
      conversion to open laparotomy, and the other outcomes are the average time of ground&#xD;
      activities, the hospital stay. The data in two groups will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2022</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the 3-year disease-free survival rate</measure>
    <time_frame>up to 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the 3-year overall survival rate</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the 5-year disease-free survival rate</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the 5-year overall survival rate</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the operation time</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total blood loss</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of pancreatic leakage</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of lymph nodes dissected</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of conversion to open laparotomy</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of bowel obstruction</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the time to firstly flaunt</measure>
    <time_frame>up to 36 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>the time of hospital stay</measure>
    <time_frame>up to 36 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gastric Cancer Stage II</condition>
  <condition>Gastric Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>The bursectomy and D2 lymphadenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The D2 lymphadenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic bursectomy and D2 lymphadenectomy</intervention_name>
    <description>The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.</description>
    <arm_group_label>The bursectomy and D2 lymphadenectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic D2 lymphadenectomy</intervention_name>
    <description>D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).</description>
    <arm_group_label>The D2 lymphadenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The age limits is 18-80 years old;&#xD;
&#xD;
          2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.&#xD;
&#xD;
          3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;&#xD;
&#xD;
          4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;&#xD;
&#xD;
          5. Criteria of performance status karnofsky is greater than or equal to 60.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients' age limits is Less than 18 years old, or more than 80 years old;&#xD;
&#xD;
          2. The preoperative imaging confirmed that the tumor involve adjacent organs;&#xD;
&#xD;
          3. The tumor have been finding distant metastases;&#xD;
&#xD;
          4. American Society of anesthesiologists (ASA) score more than 3;&#xD;
&#xD;
          5. Criteria of performance status karnofsky is lower than 60;&#xD;
&#xD;
          6. There is a laparoscopic surgery contraindications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Wan, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liao-nan Zou, professor</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Wan, professor</last_name>
    <phone>0086-020-13710637721</phone>
    <email>reiqiwj@aliyun.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liao-nan Zou, professor</last_name>
    <phone>0086-020-13423663496</phone>
    <email>13423663496@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>liao-nan Zou, professor</last_name>
      <phone>0086-020-13423663496</phone>
      <email>13423663496@163.com</email>
    </contact>
    <contact_backup>
      <last_name>xin-quan Lu, Dr</last_name>
      <phone>0086-020-18898607919</phone>
      <email>18898607919@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.</citation>
    <PMID>26170983</PMID>
  </results_reference>
  <results_reference>
    <citation>Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-4702-z. Epub 2015 Dec 16.</citation>
    <PMID>26675932</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Jin Wan</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic</keyword>
  <keyword>Bursectomy</keyword>
  <keyword>D2 lymphadenectomy</keyword>
  <keyword>Gastric Cancer</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>Yes</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/NCT02969148
org study id: LBDL1
nct id: NCT02969148
lead sponsor: 
has dmc: Yes
To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2
      lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced
      gastric cancer by prospective randomized controlled clinical trial.
To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective
      randomized controlled trial will be performed in the GI department, Guangdong provincial
      hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases
      with advanced gastric cancer, will be needed after calculated by the statistics. The 100
      cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes
      are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years'
      and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall
      survival（OS）rate, operative time, the total blood loss, the intra-operative complication and
      the post-operative complication, the number of lymph nodes dissected, the number of
      conversion to open laparotomy, and the other outcomes are the average time of ground
      activities, the hospital stay. The data in two groups will be compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: the 3-year disease-free survival rate
time frame: up to 36 months
measure: the 3-year overall survival rate
time frame: up to 36 months
measure: the 5-year disease-free survival rate
time frame: up to 5 years
measure: the 5-year overall survival rate
time frame: up to 5 years
measure: the operation time
time frame: up to 36 months
measure: the total blood loss
time frame: up to 36 months
measure: the number of pancreatic leakage
time frame: up to 36 months
measure: the number of lymph nodes dissected
time frame: up to 36 months
measure: the number of conversion to open laparotomy
time frame: up to 36 months
measure: the number of bowel obstruction
time frame: up to 36 months
measure: the time to firstly flaunt
time frame: up to 36 months
measure: the time of hospital stay
time frame: up to 36 months
arm group label: The bursectomy and D2 lymphadenectomy
arm group type: Experimental
description: Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)
arm group label: The D2 lymphadenectomy
arm group type: Active Comparator
description: Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.
intervention type: Procedure
intervention name: Laparoscopic bursectomy and D2 lymphadenectomy
description: The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.
arm group label: The bursectomy and D2 lymphadenectomy
intervention type: Procedure
intervention name: Laparoscopic D2 lymphadenectomy
description: D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
arm group label: The D2 lymphadenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jin Wan, professor
role: Principal Investigator
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
last name: Liao-nan Zou, professor
role: Study Director
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
last name: Jin Wan, professor
phone: 0086-020-13710637721
email: reiqiwj@aliyun.com
last name: Liao-nan Zou, professor
phone: 0086-020-13423663496
email: 13423663496@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.
PMID: 26170983
citation: Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-4702-z. Epub 2015 Dec 16.
PMID: 26675932
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Jin Wan
investigator title: professor
mesh term: Stomach Neoplasms
sharing ipd: Yes