<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/NCT03791450</url>
  </required_header>
  <id_info>
    <org_study_id>C201812</org_study_id>
    <nct_id>NCT03791450</nct_id>
  </id_info>
  <brief_title>Investigation of Pancreaticoduodenectomy</brief_title>
  <official_title>A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators intend to conduct a multicentre, big-sample, retrospective study to&#xD;
      analysis the surgery results of pancreaticoduodenectomy and compare the different suture&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For patients with malignant or benign disease of the pancreatic head and periampullary&#xD;
      region, pancreaticoduodenectomy is the only potential approach to radical cure. However,&#xD;
      pancreaticoduodenectomy is consider as one of the most complex operations associated with a&#xD;
      high rate of postoperative complications such as pancreatic fistula, delayed gastric&#xD;
      emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated&#xD;
      with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to&#xD;
      decrease the morbidity. But there is little evidence for the superiority of one anastomotic&#xD;
      technique over the others. Therefore, investigators intend to conduct a multicentre,&#xD;
      big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy&#xD;
      and compare the different suture technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 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>Incidence of Postoperative Pancreatic Fistula(POPF)</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>Within 90 days after surgery</time_frame>
    <description>The incidence of operative complications within 90 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The death occurred within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of operation</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The time of operation count by minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay after surgery</measure>
    <time_frame>From first day after surgery to release from hospital (anticipate 5 days minimally)</time_frame>
    <description>Days between surgery and hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>From first day after surgery to release from hospital (anticipate 5 days minimally)</time_frame>
    <description>The total hospitalization expenses</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10085</enrollment>
  <condition>Pancreaticoduodenectomy</condition>
  <arm_group>
    <arm_group_label>pancreaticoduodenectomy</arm_group_label>
    <description>patients underwent pancreaticoduodenectomy in recent ten years.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Chen Xiaoping</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03791450
org study id: C201812
nct id: NCT03791450
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators intend to conduct a multicentre, big-sample, retrospective study to
      analysis the surgery results of pancreaticoduodenectomy and compare the different suture
      technique.
For patients with malignant or benign disease of the pancreatic head and periampullary
      region, pancreaticoduodenectomy is the only potential approach to radical cure. However,
      pancreaticoduodenectomy is consider as one of the most complex operations associated with a
      high rate of postoperative complications such as pancreatic fistula, delayed gastric
      emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated
      with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to
      decrease the morbidity. But there is little evidence for the superiority of one anastomotic
      technique over the others. Therefore, investigators intend to conduct a multicentre,
      big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy
      and compare the different suture technique.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of Postoperative Pancreatic Fistula(POPF)
time frame: Within 30 days after surgery
description: The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.
measure: Morbidity
time frame: Within 90 days after surgery
description: The incidence of operative complications within 90 days after surgery
measure: Mortality
time frame: Within 30 days after surgery
description: The death occurred within 30 days after surgery
measure: Duration of operation
time frame: Intraoperative
description: The time of operation count by minute.
measure: Length of hospital stay after surgery
time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
description: Days between surgery and hospital discharge
measure: Hospital costs
time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
description: The total hospitalization expenses
arm group label: pancreaticoduodenectomy
description: patients underwent pancreaticoduodenectomy in recent ten years.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Chen Xiaoping
investigator title: Principal Investigator