<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/NCT02997098</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00078618</org_study_id>
    <nct_id>NCT02997098</nct_id>
  </id_info>
  <brief_title>Longitudinal Outcomes in Hepatic Resection</brief_title>
  <official_title>Longitudinal Outcomes in Hepatic Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational registry of patients undergoing liver surgery collects patients both&#xD;
      retrospectively and prospectively. Patients undergoing liver resection for any non-transplant&#xD;
      indication will be evaluated for clinical outcomes (such as surgical complications, survival,&#xD;
      and disease progression) based on clinical and patient factors (like indication, age, and&#xD;
      other treatments for the disease).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study design changed to clinical database only with no research question to be studied.&#xD;
  </why_stopped>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">May 2037</completion_date>
  <primary_completion_date type="Anticipated">May 2037</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>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical-site infection</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bleeding</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood clot</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of other therapy</measure>
    <time_frame>5 years</time_frame>
    <description>e.g., antibiotics in liver abscess, chemotherapy in liver cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of segments resected</measure>
    <time_frame>1 day</time_frame>
    <description>If applicable</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Patients undergoing hepatectomy</arm_group_label>
    <description>Patients undergoing hepatectomy, or liver resection, for a non-transplant indication.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing liver resection for non-transplant indications.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring liver resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years&#xD;
&#xD;
          -  Patients undergoing liver transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabino Zani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DUHS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</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/NCT02997098
org study id: Pro00078618
nct id: NCT02997098
lead sponsor: 
has dmc: No
This observational registry of patients undergoing liver surgery collects patients both
      retrospectively and prospectively. Patients undergoing liver resection for any non-transplant
      indication will be evaluated for clinical outcomes (such as surgical complications, survival,
      and disease progression) based on clinical and patient factors (like indication, age, and
      other treatments for the disease).
observational model: Cohort
time perspective: Other
measure: Overall survival
time frame: 10 years
measure: Disease-free survival
time frame: 10 years
measure: Surgical-site infection
time frame: 3 months
measure: Postoperative bleeding
time frame: 3 months
measure: Blood clot
time frame: 3 months
measure: Use of other therapy
time frame: 5 years
description: e.g., antibiotics in liver abscess, chemotherapy in liver cancer
measure: Operative time
time frame: 1 day
measure: Intraoperative blood loss
time frame: 1 day
measure: Number of segments resected
time frame: 1 day
description: If applicable
arm group label: Patients undergoing hepatectomy
description: Patients undergoing hepatectomy, or liver resection, for a non-transplant indication.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sabino Zani, MD
role: Principal Investigator
affiliation: DUHS
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No