<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/NCT04481828</url>
  </required_header>
  <id_info>
    <org_study_id>2019-98</org_study_id>
    <nct_id>NCT04481828</nct_id>
  </id_info>
  <brief_title>Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer</brief_title>
  <official_title>Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli Derince Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In&#xD;
      other regions where tumor incidence is relatively low and patient characteristics are&#xD;
      different, developments in this issue have been limited. In this study, the investigators&#xD;
      aimed to compare the early results for patients who underwent open or laparoscopic&#xD;
      gastrectomy for gastric cancer in a center in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients who were operated in Kocaeli Derince Training and Research Hospital between&#xD;
      January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The&#xD;
      diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical&#xD;
      staging was done using contrast computed tomography (CT). Positron emission tomography (PET)&#xD;
      was used in patients with suspected metastasis.The patients were divided into two groups&#xD;
      according to the technique applied (open, laparotomy). The first group (Group 1; n: 30)&#xD;
      consisted of patients who underwent open surgery, and the second group (Group 2, n: 30)&#xD;
      laparoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Age</measure>
    <time_frame>2014-2019</time_frame>
    <description>year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>2014- 2019</time_frame>
    <description>kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Previous abdominal surgery status</measure>
    <time_frame>2014-2019</time_frame>
    <description>yes or no</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comorbidity status</measure>
    <time_frame>2014 -2019</time_frame>
    <description>present or absent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neoadjuvant therapy status</measure>
    <time_frame>2014-2019</time_frame>
    <description>present or absent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>American Society of Anesthesiologists (ASA) score</measure>
    <time_frame>2014-2019</time_frame>
    <description>1,2,3,4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender</measure>
    <time_frame>2014-2019</time_frame>
    <description>male or female</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical technique</measure>
    <time_frame>2014-2019</time_frame>
    <description>open or laparoscopic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor localization</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>proximal, middle, lower</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrectomy type</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>total, subtotal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymph node dissection type</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>D1+, D2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operation time</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication (Clavien-Dindo Classification)</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>present or absent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of harvested lymph node</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>number</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resection margin status</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>positive or negative</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor stage (American Joint Committee on Cancer 8th Edition)</measure>
    <time_frame>2014 - 2019</time_frame>
    <description>0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>open gastrectomy</arm_group_label>
    <description>The first group (Group 1; n: 30) consisted of patients who underwent open surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic gastrectomy</arm_group_label>
    <description>The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastrectomy</intervention_name>
    <description>gastric resection with lymph node dissection(D1+,D2) for stomach cancer.</description>
    <arm_group_label>laparoscopic gastrectomy</arm_group_label>
    <arm_group_label>open gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who were operated in Kocaeli Derince Training and Research Hospital between&#xD;
        January 2014 and January 2019 consecutively due to gastric cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gastric cancer(adenocarcinoma) proven biopsy&#xD;
&#xD;
          -  Operated by same surgical team&#xD;
&#xD;
          -  Presence of distant metastasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent palliative resection&#xD;
&#xD;
          -  operated by a different surgical team&#xD;
&#xD;
          -  ASA score: 4&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kocaeli Derince Training and research Hospital</name>
      <address>
        <city>Kocasinan</city>
        <state>Derince</state>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.</citation>
    <PMID>27401443</PMID>
  </reference>
  <reference>
    <citation>van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.</citation>
    <PMID>28730391</PMID>
  </reference>
  <reference>
    <citation>Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.</citation>
    <PMID>26603678</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli Derince Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Adem Yuksel</investigator_full_name>
    <investigator_title>M.D. Department of Gastroenterological surgery,Principal Investigator</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04481828
org study id: 2019-98
nct id: NCT04481828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In
      other regions where tumor incidence is relatively low and patient characteristics are
      different, developments in this issue have been limited. In this study, the investigators
      aimed to compare the early results for patients who underwent open or laparoscopic
      gastrectomy for gastric cancer in a center in Turkey.
The patients who were operated in Kocaeli Derince Training and Research Hospital between
      January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The
      diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical
      staging was done using contrast computed tomography (CT). Positron emission tomography (PET)
      was used in patients with suspected metastasis.The patients were divided into two groups
      according to the technique applied (open, laparotomy). The first group (Group 1; n: 30)
      consisted of patients who underwent open surgery, and the second group (Group 2, n: 30)
      laparoscopic surgery.
observational model: Cohort
time perspective: Retrospective
measure: Age
time frame: 2014-2019
description: year
measure: Body mass index
time frame: 2014- 2019
description: kg/m2
measure: Previous abdominal surgery status
time frame: 2014-2019
description: yes or no
measure: Comorbidity status
time frame: 2014 -2019
description: present or absent
measure: Neoadjuvant therapy status
time frame: 2014-2019
description: present or absent
measure: American Society of Anesthesiologists (ASA) score
time frame: 2014-2019
description: 1,2,3,4
measure: Gender
time frame: 2014-2019
description: male or female
measure: Surgical technique
time frame: 2014-2019
description: open or laparoscopic
measure: Tumor localization
time frame: 2014 - 2019
description: proximal, middle, lower
measure: Gastrectomy type
time frame: 2014 - 2019
description: total, subtotal
measure: Lymph node dissection type
time frame: 2014 - 2019
description: D1+, D2
measure: Operation time
time frame: 2014 - 2019
description: minute
measure: Blood loss
time frame: 2014 - 2019
description: ml
measure: Complication (Clavien-Dindo Classification)
time frame: 2014 - 2019
description: 1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)
measure: 30-day mortality
time frame: 2014 - 2019
description: present or absent
measure: Number of harvested lymph node
time frame: 2014 - 2019
description: number
measure: Resection margin status
time frame: 2014 - 2019
description: positive or negative
measure: Tumor stage (American Joint Committee on Cancer 8th Edition)
time frame: 2014 - 2019
description: 0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)
arm group label: open gastrectomy
description: The first group (Group 1; n: 30) consisted of patients who underwent open surgery
arm group label: laparoscopic gastrectomy
description: The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy
intervention type: Procedure
intervention name: gastrectomy
description: gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
arm group label: laparoscopic gastrectomy
arm group label: open gastrectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.
PMID: 27401443
citation: van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.
PMID: 28730391
citation: Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.
PMID: 26603678
responsible party type: Principal Investigator
investigator affiliation: Kocaeli Derince Education and Research Hospital
investigator full name: Adem Yuksel
investigator title: M.D. Department of Gastroenterological surgery,Principal Investigator
mesh term: Stomach Neoplasms
sharing ipd: Undecided