<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/NCT03234166</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0246</org_study_id>
    <nct_id>NCT03234166</nct_id>
  </id_info>
  <brief_title>Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis</brief_title>
  <acronym>PANIC</acronym>
  <official_title>Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in&#xD;
      case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of&#xD;
      evolution. The step up approach is now widely recommended for the management of IPN. In fact,&#xD;
      in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first,&#xD;
      supported by probabilist antibiotherapy. 1/3 of patients won't require any other&#xD;
      interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was&#xD;
      formally realized by open laparotomy. Since de last decade, mini-invasive technics have&#xD;
      emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and&#xD;
      permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a&#xD;
      nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections&#xD;
      heterogeneity) which are negative predictors for success of catheter drainage in IPN with an&#xD;
      receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate&#xD;
      on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success.&#xD;
      Secondary aims are to evaluate possible others predictors for success of catheter drainage in&#xD;
      IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need&#xD;
      for an additional necrosectomy regarding its type and duration, as well as the emergence of&#xD;
      multiresistance organism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using electronic patient data monitoring systems, the investigators reviewed all patients&#xD;
      with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity&#xD;
      or ICUs at the Nantes University Hospital, Rennes, Angers and Brest University Hospital from&#xD;
      January 1, 2012, to december 31, 2017. For enrolled patients, general clinical&#xD;
      characteristics were collected. Patients were categorized into two groups according to&#xD;
      success of catheter drainage or failure of catheter drainage, and the differences of these&#xD;
      characteristics between two groups were evaluated. The Hollemans nomogram is evaluate and&#xD;
      potential risk factors will be collected and studied by using multiple logistic regression&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>ROC curve of Hollemans nomogram</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Nomogram based on 4 variables independently associated with success of catheter drainage: Male sex, multiple organ failure, increasing percentage of pancreatic necrosis and heterogeneity of the collection . Points are awarded to a factor if it is associated with a reduced success chance of catheter drainage. Favorable scores for all factors (ie, 0 points), result in a 91% success chance of primary catheter drainage. Similarly, unfavorable scores (maximum of 40 points) result in a 2% success chance of primary catheter drainage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Potential Predictors of catheter drainage failure</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure</description>
  </secondary_outcome>
  <enrollment type="Actual">72</enrollment>
  <condition>Acute Necrotizing Pancreatitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non interventional study</intervention_name>
    <description>Only data will be taken of patient's file.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Major patient, hospitalized with a diagnosis of acute necrotizing pancreatitis between 2012&#xD;
        and 2016, whatever the etiology, complicated by a necrosis infection infection (either&#xD;
        proven or strongly suspected) requiring the initiation of antibiotic therapy and a drainage&#xD;
        gesture of this CCM.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age &gt;18 years) with acute necrotizing pancreatitis&#xD;
&#xD;
          -  IPN proven or highly suspected (proven=positive cultures on pancreatic collections or&#xD;
             gas on CT, highly suspected= sepsis without any others infection)&#xD;
&#xD;
          -  The need for a catheter drainage&#xD;
&#xD;
        Non inclusion Criteria:&#xD;
&#xD;
          -  patients under 18 years&#xD;
&#xD;
          -  lack of radiologic evidence to diagnose acute necrotizing pancreatitis,&#xD;
&#xD;
          -  no suspicion or confirmation of IPN&#xD;
&#xD;
          -  no need for a drainage&#xD;
&#xD;
          -  unable to receive a drainage&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brest University Hospital</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Acute Necrotizing</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03234166
org study id: RC17_0246
nct id: NCT03234166
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in
      case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of
      evolution. The step up approach is now widely recommended for the management of IPN. In fact,
      in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first,
      supported by probabilist antibiotherapy. 1/3 of patients won't require any other
      interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was
      formally realized by open laparotomy. Since de last decade, mini-invasive technics have
      emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and
      permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a
      nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections
      heterogeneity) which are negative predictors for success of catheter drainage in IPN with an
      receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate
      on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success.
      Secondary aims are to evaluate possible others predictors for success of catheter drainage in
      IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need
      for an additional necrosectomy regarding its type and duration, as well as the emergence of
      multiresistance organism.
Using electronic patient data monitoring systems, the investigators reviewed all patients
      with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity
      or ICUs at the Nantes University Hospital, Rennes, Angers and Brest University Hospital from
      January 1, 2012, to december 31, 2017. For enrolled patients, general clinical
      characteristics were collected. Patients were categorized into two groups according to
      success of catheter drainage or failure of catheter drainage, and the differences of these
      characteristics between two groups were evaluated. The Hollemans nomogram is evaluate and
      potential risk factors will be collected and studied by using multiple logistic regression
      analysis.
observational model: Cohort
time perspective: Retrospective
measure: ROC curve of Hollemans nomogram
time frame: up to 4 months
description: Nomogram based on 4 variables independently associated with success of catheter drainage: Male sex, multiple organ failure, increasing percentage of pancreatic necrosis and heterogeneity of the collection . Points are awarded to a factor if it is associated with a reduced success chance of catheter drainage. Favorable scores for all factors (ie, 0 points), result in a 91% success chance of primary catheter drainage. Similarly, unfavorable scores (maximum of 40 points) result in a 2% success chance of primary catheter drainage.
measure: Potential Predictors of catheter drainage failure
time frame: up to 4 months
description: Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure
intervention type: Other
intervention name: Non interventional study
description: Only data will be taken of patient's file.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pancreatitis, Acute Necrotizing
mesh term: Necrosis
sharing ipd: Undecided