xml: <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/NCT05978076</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN472021/CHUSTE</org_study_id>
      <nct_id>NCT05978076</nct_id>
    </id_info>
    <brief_title>Serum Lipase and Severity of Pancreatic Injury.</brief_title>
    <official_title>Serum Lipase and Severity of Pancreatic Injury.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        Diagnosis of pancreas injury is not easy at first consult. It's a retrospective study, in&#xD;
        children under 15 years and 3months, between January 1st 2010 to August 31th 2019, to prove&#xD;
        that the first level of lipase is correlated with the severity of pancreatic injury.&#xD;
  &#xD;
        Every children with elevated serum lipase after trauma during those years will be selected.&#xD;
  &#xD;
        The children with pancreatic tumors will be excluded. American Association of Surgeon Trauma&#xD;
        (AAST) classification of pancreas injury will be used to grade severity.&#xD;
  &#xD;
        Children will be divided in two groups : one including pancreatic lesion with duct injury and&#xD;
        one without duct injury.&#xD;
  &#xD;
        Data will include mechanism of injury, associated injury, length of stay, maximal lipase&#xD;
        level, nutritional care and local complications will be noted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main objective of this study is to determine if there is a correlation between the&#xD;
        initial serum lipase and the severity of the pancreatic injury.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">December 30, 2021</completion_date>
    <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>lipase level in severe pancreatic injury (duct injury)</measure>
      <time_frame>Month: 9 (end of study)</time_frame>
      <description>Collected in medical history.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>lipase level in light pancreatic injury (without duct injury)</measure>
      <time_frame>Month: 9 (end of study)</time_frame>
      <description>Collected in medical history.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Local complications</measure>
      <time_frame>Month: 9 (end of study)</time_frame>
      <description>Collected in medical history.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximal lipase level</measure>
      <time_frame>Month: 9 (end of study)</time_frame>
      <description>Collected in medical history.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">91</enrollment>
    <condition>Pancreatic Injury</condition>
    <arm_group>
      <arm_group_label>Every children with elevated serum lipase</arm_group_label>
      <description>Every children with elevated serum lipase after trauma during those years will be included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>data collection</intervention_name>
      <description>data collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications.</description>
      <arm_group_label>Every children with elevated serum lipase</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children under 15 years 3 months with elevated lipase serum level after trauma will be&#xD;
          included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children under 15 years 3 months with elevated lipase serum level after trauma.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Elevation of lipase secondary to pancreatic tumor&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aurélien SCALABRE, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint-Etienne</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lipase</keyword>
    <keyword>Pancreatic trauma</keyword>
    <keyword>Pseudocysts</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978076
  org study id: IRBN472021/CHUSTE
  nct id: NCT05978076
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Diagnosis of pancreas injury is not easy at first consult. It's a retrospective study, in
        children under 15 years and 3months, between January 1st 2010 to August 31th 2019, to prove
        that the first level of lipase is correlated with the severity of pancreatic injury.
  
        Every children with elevated serum lipase after trauma during those years will be selected.
  
        The children with pancreatic tumors will be excluded. American Association of Surgeon Trauma
        (AAST) classification of pancreas injury will be used to grade severity.
  
        Children will be divided in two groups : one including pancreatic lesion with duct injury and
        one without duct injury.
  
        Data will include mechanism of injury, associated injury, length of stay, maximal lipase
        level, nutritional care and local complications will be noted.
  The main objective of this study is to determine if there is a correlation between the
        initial serum lipase and the severity of the pancreatic injury.
  observational model: Case-Only
  time perspective: Retrospective
  measure: lipase level in severe pancreatic injury (duct injury)
  time frame: Month: 9 (end of study)
  description: Collected in medical history.
  measure: lipase level in light pancreatic injury (without duct injury)
  time frame: Month: 9 (end of study)
  description: Collected in medical history.
  measure: Local complications
  time frame: Month: 9 (end of study)
  description: Collected in medical history.
  measure: Maximal lipase level
  time frame: Month: 9 (end of study)
  description: Collected in medical history.
  arm group label: Every children with elevated serum lipase
  description: Every children with elevated serum lipase after trauma during those years will be included.
  intervention type: Other
  intervention name: data collection
  description: data collection : mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications.
  arm group label: Every children with elevated serum lipase
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 15 Years
  healthy volunteers: No
  last name: Aurélien SCALABRE, MD
  role: Principal Investigator
  affiliation: CHU Saint-Etienne
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Wounds and Injuries
  sharing ipd: No