<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/NCT04448795</url>
  </required_header>
  <id_info>
    <org_study_id>202000980B0</org_study_id>
    <nct_id>NCT04448795</nct_id>
  </id_info>
  <brief_title>Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy</brief_title>
  <official_title>Significance of Drain Amylase Levels After Pancreaticoduodenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      This study investigated the impact of highest drain fluid amylase (DFA) level on&#xD;
      postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing&#xD;
      pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and&#xD;
      clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using&#xD;
      binary logistic regression. Receiver operating characteristic curve analysis was performed to&#xD;
      determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators&#xD;
      compared length of hospital stay, surgical mortality rates, and need for postoperative&#xD;
      interventions by highest DFA level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2010</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>postoperative pancreatic fistula</measure>
    <time_frame>through study completion, an average of 2 month</time_frame>
    <description>fluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative interventions</measure>
    <time_frame>through study completion, an average of 2 month</time_frame>
    <description>transarterial embolization, image-guided second drainage, and reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>through study completion, an average of 2 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality rates</measure>
    <time_frame>30 day</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Pancreas; Fistula</condition>
  <eligibility>
    <study_pop>
      <textblock>
        underwent PD in Chang Gung Memorial Hospital at Linkou&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  underwent PD from October 2010 to September 2018 in our institution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 20 years of age&#xD;
&#xD;
          -  clinical information was unavailable due to private or legal issues&#xD;
&#xD;
          -  receiving PD without pancreaticojejunostomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</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>Pancreatic Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT04448795
org study id: 202000980B0
nct id: NCT04448795
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigated the impact of highest drain fluid amylase (DFA) level on
      postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing
      pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and
      clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using
      binary logistic regression. Receiver operating characteristic curve analysis was performed to
      determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators
      compared length of hospital stay, surgical mortality rates, and need for postoperative
      interventions by highest DFA level.
observational model: Cohort
time perspective: Retrospective
measure: postoperative pancreatic fistula
time frame: through study completion, an average of 2 month
description: fluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value
measure: postoperative interventions
time frame: through study completion, an average of 2 month
description: transarterial embolization, image-guided second drainage, and reoperation
measure: length of hospital stay
time frame: through study completion, an average of 2 month
measure: 30-day mortality rates
time frame: 30 day
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Pancreatic Fistula
mesh term: Fistula
sharing ipd: No