<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/NCT03282253</url>
  </required_header>
  <id_info>
    <org_study_id>ESCDEPDSSAP</org_study_id>
    <nct_id>NCT03282253</nct_id>
  </id_info>
  <brief_title>Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis</brief_title>
  <official_title>Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investgatiors aimed to investigate the associations between serum levels&#xD;
      of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of&#xD;
      adverse clinical events, such as local complications, organ failure, mortality and so on.In&#xD;
      this prospective study, participants were divided into two groups based on serum SCD-1&#xD;
      concentration on admission and prospectively observe the disease severity and clinical&#xD;
      outcomes of them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>the incidence rate of infected pancreatic necrosis</measure>
    <time_frame>2-4 week after disease onset</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence rate of organ failure</measure>
    <time_frame>1-2 week after disease onset</time_frame>
    <description>the incidence rate of organ failure (transient or persistent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence rate of local complications</measure>
    <time_frame>1-2 week after disease onset</time_frame>
    <description>acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis</description>
  </secondary_outcome>
  <enrollment type="Anticipated">216</enrollment>
  <condition>Acute Pancreatitis</condition>
  <condition>Organ Failure, Multiple</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with the diagnosis of acute pancreatitis (Atlanta standard), abdominal pain&#xD;
        occurred within one week of admission; we intended to include the severer cases (APACHEII&#xD;
        score is more than 8 and Ranson score is greater than 3).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one&#xD;
             week of admission;&#xD;
&#xD;
          2. APACHEII score is more than 8 and Ranson score is greater than 3;&#xD;
&#xD;
          3. Age 18-75;&#xD;
&#xD;
          4. Obtaining informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy pancreatitis;&#xD;
&#xD;
          2. Patients with the following disease history: severe cardiac, pulmonary, renal, liver&#xD;
             function insufficiency or immunodeficiency disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 23, 2017</last_update_submitted>
  <last_update_submitted_qc>November 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing University School of Medicine</investigator_affiliation>
    <investigator_full_name>Weiqin Li</investigator_full_name>
    <investigator_title>Director of Department of Surgical Intensive Care Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Multiple Organ Failure</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/NCT03282253
org study id: ESCDEPDSSAP
nct id: NCT03282253
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, the investgatiors aimed to investigate the associations between serum levels
      of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of
      adverse clinical events, such as local complications, organ failure, mortality and so on.In
      this prospective study, participants were divided into two groups based on serum SCD-1
      concentration on admission and prospectively observe the disease severity and clinical
      outcomes of them.
observational model: Cohort
time perspective: Prospective
measure: the incidence rate of infected pancreatic necrosis
time frame: 2-4 week after disease onset
measure: the incidence rate of organ failure
time frame: 1-2 week after disease onset
description: the incidence rate of organ failure (transient or persistent)
measure: the incidence rate of local complications
time frame: 1-2 week after disease onset
description: acute peripancreatic fluid collections, pancreatic pseudocycts, acute necrotic collections and walled-off necrosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Nanjing University School of Medicine
investigator full name: Weiqin Li
investigator title: Director of Department of Surgical Intensive Care Unit
mesh term: Pancreatitis
mesh term: Multiple Organ Failure