<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/NCT03801070</url>
  </required_header>
  <id_info>
    <org_study_id>201707053</org_study_id>
    <nct_id>NCT03801070</nct_id>
  </id_info>
  <brief_title>Rad Predictors for WON</brief_title>
  <official_title>Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oklahoma Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University Chicago Illinois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Luke's Hospital University of Missouri-Kansas City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      This is a retrospective chart review study examining 1) demographic data such as age, sex,&#xD;
      etiology of pancreatitis 2) clinical data including radiological characteristics of walled&#xD;
      off pancreatic necrosis, walled off necrosis related admissions and readmission following&#xD;
      endoscopic drainage, surgical or percutaneous procedures performed for the management of&#xD;
      walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including&#xD;
      hospital readmissions, WON resolution, procedure complications, WON related death) 3)&#xD;
      endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic&#xD;
      procedures performed for management of walled off necrosis (including additional EGD's,&#xD;
      endoscopic drainage procedures, and/or necrosectomy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify WON imaging characteristics on cat-scan</measure>
    <time_frame>through study completion, an average of 260 days</time_frame>
    <description>Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)</measure>
    <time_frame>through study completion, an average of 260 days</time_frame>
    <description>Imaging classification method to efficiently report these imaging characteristics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)</measure>
    <time_frame>through study completion, an average of 260 days</time_frame>
    <description>Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>Walled Off Pancreatic Necrosis (WON)</condition>
  <arm_group>
    <arm_group_label>Less than median number necrosectomies</arm_group_label>
    <description>Group one includes patients who underwent less than median number necrosectomies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At least the median number of necrosectomies</arm_group_label>
    <description>Group two includes patients who underwent at least the median number of necrosectomies</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic drainage of walled off pancreatic necrosis</intervention_name>
    <description>transmural drainage and mechanical debridement of solid debris (necrosectomy)</description>
    <arm_group_label>At least the median number of necrosectomies</arm_group_label>
    <arm_group_label>Less than median number necrosectomies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with organized collections that contain both solid and liquid debris and arise&#xD;
        from necrotizing pancreatitis, referred to as walled off pancreatic necrosis (WON)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age who underwent endoscopic drainage of walled off&#xD;
             pancreatic necrosis&#xD;
&#xD;
          -  Patients who did not require further intervention (either surgical, percutaneous, or&#xD;
             endoscopic) following endoscopic drainage&#xD;
&#xD;
          -  Patients who required further intervention for walled off pancreatic necrosis (either&#xD;
             surgical, percutaneous, or endoscopic) following endoscopic drainage.&#xD;
&#xD;
          -  Patients who underwent percutaneous or surgical interventions prior to endoscopic&#xD;
             drainage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pancreatic pseudocysts without any solid debris&#xD;
&#xD;
          -  Under 18 years of age at the time of endoscopic drainage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University School of Medicine in St Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>July 20, 2019</last_update_submitted>
  <last_update_submitted_qc>July 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis, Acute Necrotizing</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03801070
org study id: 201707053
nct id: NCT03801070
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective chart review study examining 1) demographic data such as age, sex,
      etiology of pancreatitis 2) clinical data including radiological characteristics of walled
      off pancreatic necrosis, walled off necrosis related admissions and readmission following
      endoscopic drainage, surgical or percutaneous procedures performed for the management of
      walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including
      hospital readmissions, WON resolution, procedure complications, WON related death) 3)
      endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic
      procedures performed for management of walled off necrosis (including additional EGD's,
      endoscopic drainage procedures, and/or necrosectomy)
observational model: Case-Control
time perspective: Retrospective
measure: Identify WON imaging characteristics on cat-scan
time frame: through study completion, an average of 260 days
description: Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis
measure: Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)
time frame: through study completion, an average of 260 days
description: Imaging classification method to efficiently report these imaging characteristics
measure: Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)
time frame: through study completion, an average of 260 days
description: Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis.
arm group label: Less than median number necrosectomies
description: Group one includes patients who underwent less than median number necrosectomies
arm group label: At least the median number of necrosectomies
description: Group two includes patients who underwent at least the median number of necrosectomies
intervention type: Procedure
intervention name: endoscopic drainage of walled off pancreatic necrosis
description: transmural drainage and mechanical debridement of solid debris (necrosectomy)
arm group label: At least the median number of necrosectomies
arm group label: Less than median number necrosectomies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatitis, Acute Necrotizing
mesh term: Necrosis
sharing ipd: No