<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/NCT02223325</url>
  </required_header>
  <id_info>
    <org_study_id>YOnal - 001</org_study_id>
    <nct_id>NCT02223325</nct_id>
  </id_info>
  <brief_title>Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis</brief_title>
  <official_title>Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To compare the prognosis of acute pancreatitis between geriatric and other adult&#xD;
           patients&#xD;
&#xD;
        -  To evaluate the efficacy of various prognostic scores in geriatric patients with acute&#xD;
           pancreatitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate in geriatric patients with acute pancreatitis</measure>
    <time_frame>Within 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate in geriatric patients with acute pancreatitis</measure>
    <time_frame>Within 3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The validity of various prognostic scores in geriatric patients with acute pancreatitis</measure>
    <time_frame>Within 3 months</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Elderly, acute pancreatitis</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adults &lt;65 y, acute pancreatitis</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary care patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Acute pancreatitis Hospitalisation Adult patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent pancreatitis&#xD;
&#xD;
          -  Chronic pancreatitis&#xD;
&#xD;
          -  Outpatient follow up&#xD;
&#xD;
          -  Loss of follow up within 3 months of discharge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>November 19, 2015</last_update_submitted>
  <last_update_submitted_qc>November 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Ibrahim Koral Onal</investigator_full_name>
    <investigator_title>MD, associate professor</investigator_title>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</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/NCT02223325
org study id: YOnal - 001
nct id: NCT02223325
lead sponsor: 
has dmc: No
-  To compare the prognosis of acute pancreatitis between geriatric and other adult
           patients

        -  To evaluate the efficacy of various prognostic scores in geriatric patients with acute
           pancreatitis
observational model: Case-Control
time perspective: Prospective
measure: Mortality rate in geriatric patients with acute pancreatitis
time frame: Within 3 months
measure: Morbidity rate in geriatric patients with acute pancreatitis
time frame: Within 3 months
measure: The validity of various prognostic scores in geriatric patients with acute pancreatitis
time frame: Within 3 months
arm group label: Elderly, acute pancreatitis
description: No intervention
arm group label: Adults <65 y, acute pancreatitis
description: No intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Ibrahim Koral Onal
investigator title: MD, associate professor
mesh term: Pancreatitis