<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/NCT03777540</url>
  </required_header>
  <id_info>
    <org_study_id>Gastric Cancer Surgery</org_study_id>
    <nct_id>NCT03777540</nct_id>
  </id_info>
  <brief_title>Gastric Cancer Surgery in Elderly Patients</brief_title>
  <acronym>GCSEP</acronym>
  <official_title>Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</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>
      Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in&#xD;
      aged population because of general health condition may affect the postoperative result. Aim&#xD;
      of the study was to identify risk factors for post-operative mortality in octogenarian&#xD;
      patients who underwent surgery for gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      236 patients (181: 80-85 years old and 55: &gt;85 years old) underwent surgery for gastric&#xD;
      cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The&#xD;
      variables of the two groups of patients were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality</measure>
    <time_frame>Up to 90-days</time_frame>
    <description>mortality occurred up to 90 days from surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 5-years</time_frame>
    <description>Overall survival was defined as the time from the date of surgery to patient death (including surgery-associated death or hospital death), or the date of last available information concerning vital status.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">236</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Age; timing of gastric resection</arm_group_label>
    <description>Patients 80-85 years; Patients &gt; 85 years; Elective and urgent surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric resection</intervention_name>
    <description>Partial gastrectomy with jejunal anastomosis,&quot; &quot;total gastrectomy,&quot; &quot;gastroenterostomy without gastrectomy&quot; or &quot;other&quot; (palliative surgery).</description>
    <arm_group_label>Age; timing of gastric resection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        236 patients (181: 80-85 years old and 55: &gt;85 years old) underwent surgery for gastric&#xD;
        cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed primary gastric cancer submitted to surgical&#xD;
             treatment;&#xD;
&#xD;
          -  Age &gt; 80 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed primary gastric cancer submitted to surgical&#xD;
             treatment and age &lt; 80 years;&#xD;
&#xD;
          -  Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases&#xD;
             submitted to surgical treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno Nardo, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Bologna</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Marialuisa Lugaresi</investigator_full_name>
    <investigator_title>Adjunct Professor</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/NCT03777540
org study id: Gastric Cancer Surgery
nct id: NCT03777540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in
      aged population because of general health condition may affect the postoperative result. Aim
      of the study was to identify risk factors for post-operative mortality in octogenarian
      patients who underwent surgery for gastric cancer.
236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric
      cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The
      variables of the two groups of patients were compared.
observational model: Cohort
time perspective: Retrospective
measure: Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality
time frame: Up to 90-days
description: mortality occurred up to 90 days from surgery
measure: Overall survival
time frame: Up to 5-years
description: Overall survival was defined as the time from the date of surgery to patient death (including surgery-associated death or hospital death), or the date of last available information concerning vital status.
arm group label: Age; timing of gastric resection
description: Patients 80-85 years; Patients > 85 years; Elective and urgent surgery.
intervention type: Procedure
intervention name: Gastric resection
description: Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).
arm group label: Age; timing of gastric resection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 80 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bruno Nardo, MD,PhD
role: Study Chair
affiliation: University of Bologna
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Marialuisa Lugaresi
investigator title: Adjunct Professor
mesh term: Stomach Neoplasms