<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/NCT04429841</url>
  </required_header>
  <id_info>
    <org_study_id>302764</org_study_id>
    <nct_id>NCT04429841</nct_id>
  </id_info>
  <brief_title>D2 Versus D1 Gastrectomy of Operable Gastric Cancer</brief_title>
  <official_title>Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of&#xD;
      lymph node (LN) dissection is controversial. The aim of this observational study is to assess&#xD;
      the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma&#xD;
      regarding operative and long term oncological outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational study included 80 consecutive patients presented by operable gastric&#xD;
      cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and&#xD;
      January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer&#xD;
      treated by D1 gastrectomy earlier during the same period were included as a control (Group&#xD;
      II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen&#xD;
      computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and&#xD;
      D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all&#xD;
      patients. The type of gastrectomy (distal or total) was done according to the site of the&#xD;
      tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the&#xD;
      proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or&#xD;
      pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients&#xD;
      with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done&#xD;
      as outpatient visits for average 5 years. Both groups were compared regarding postoperative&#xD;
      morbidity and mortality, disease recurrence and survival rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2010</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative morbidity rate</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Frequency of early postoperative complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operative mortality rate</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Frequency of early postoperative mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5 years Recurrence rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Frequency of tumor recurrence within 5 years after curative surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 years Cancer specific mortality rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Frequency of Cancer specific mortality within 5 years after curative surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 years Disease free survival rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Percentage of patients survived for 5 years after surgery without tumor recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 years Overall survival rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Percentage of patients survived for 5 years after surgery with/without tumor recurrence</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">148</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>D1 Gastrectomy</arm_group_label>
    <description>Patients are managed by radical gastrectomy with D1 lymphadenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2 Gastrectomy</arm_group_label>
    <description>Patients are managed by radical gastrectomy with D2 lymphadenectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical gastrectomy with D1 lymphadenectomy</intervention_name>
    <arm_group_label>D1 Gastrectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical gastrectomy with D2 lymphadenectomy</intervention_name>
    <arm_group_label>D2 Gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This observational study included 80 consecutive patients presented by operable gastric&#xD;
        cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and&#xD;
        January 2016, (Group I). Another 68 consecutive patients presented by operable gastric&#xD;
        cancer treated by D1 gastrectomy earlier during the same period were included as a control&#xD;
        (Group II).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 80 years with a histologically confirmed operable adenocarcinoma&#xD;
             of the stomach with complete follow up after surgery for average 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated gastric cancer (obstructed or perforated)&#xD;
&#xD;
          -  Irresectable or metastatic disease&#xD;
&#xD;
          -  Previous or coexisting cancer&#xD;
&#xD;
          -  Prior gastric surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Elmessiry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.</citation>
    <PMID>22312521</PMID>
  </reference>
  <reference>
    <citation>Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.</citation>
    <PMID>15082726</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mohamed El Messiry</investigator_full_name>
    <investigator_title>Assistant professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Operable Gastric Cancer</keyword>
  <keyword>D2 Gastrectomy</keyword>
  <keyword>D1 Gastrectomy</keyword>
  <keyword>Operative Mortality &amp; Morbidity</keyword>
  <keyword>Oncological Outcomes</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/NCT04429841
org study id: 302764
nct id: NCT04429841
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of
      lymph node (LN) dissection is controversial. The aim of this observational study is to assess
      the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma
      regarding operative and long term oncological outcomes.
This observational study included 80 consecutive patients presented by operable gastric
      cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and
      January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer
      treated by D1 gastrectomy earlier during the same period were included as a control (Group
      II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen
      computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and
      D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all
      patients. The type of gastrectomy (distal or total) was done according to the site of the
      tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the
      proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or
      pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients
      with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done
      as outpatient visits for average 5 years. Both groups were compared regarding postoperative
      morbidity and mortality, disease recurrence and survival rates.
observational model: Case-Control
time perspective: Other
measure: Postoperative morbidity rate
time frame: 30 days after surgery
description: Frequency of early postoperative complications
measure: Operative mortality rate
time frame: 30 days after surgery
description: Frequency of early postoperative mortality
measure: 5 years Recurrence rate
time frame: 5 years after surgery
description: Frequency of tumor recurrence within 5 years after curative surgery
measure: 5 years Cancer specific mortality rate
time frame: 5 years after surgery
description: Frequency of Cancer specific mortality within 5 years after curative surgery
measure: 5 years Disease free survival rate
time frame: 5 years after surgery
description: Percentage of patients survived for 5 years after surgery without tumor recurrence
measure: 5 years Overall survival rate
time frame: 5 years after surgery
description: Percentage of patients survived for 5 years after surgery with/without tumor recurrence
arm group label: D1 Gastrectomy
description: Patients are managed by radical gastrectomy with D1 lymphadenectomy
arm group label: D2 Gastrectomy
description: Patients are managed by radical gastrectomy with D2 lymphadenectomy
intervention type: Procedure
intervention name: Radical gastrectomy with D1 lymphadenectomy
arm group label: D1 Gastrectomy
intervention type: Procedure
intervention name: Radical gastrectomy with D2 lymphadenectomy
arm group label: D2 Gastrectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
last name: Mohamed Elmessiry, MD
role: Principal Investigator
affiliation: Assistant Professor of Surgery
facility: 
country: Egypt
citation: Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.
PMID: 22312521
citation: Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
PMID: 15082726
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mohamed El Messiry
investigator title: Assistant professor of Surgery
mesh term: Stomach Neoplasms