<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/NCT03275883</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01889</org_study_id>
    <nct_id>NCT03275883</nct_id>
  </id_info>
  <brief_title>Arterial Patency in Liver Transplantation</brief_title>
  <official_title>Retrospective Analysis to Identify Independent Predictive Risk Factors for Early and Late Arterial Occlusion in Liver Transplantation and Compare Short and Long-term Outcomes for Aorto-hepatic Conduits in Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</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>
      The aim of this study is to determine the risk profile of hepatic artery occlusion in liver&#xD;
      transplant recipients who received an aortohepatic conduits, analyzing all consecutive&#xD;
      cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will&#xD;
      be examined and adverse events will be analyzed and categorized using the Clavien-Dindo&#xD;
      classification and Comprehensive Complication Index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      Arterial conduits in liver transplantation are almost as old as the procedure itself. First&#xD;
      described by Starzl in 1984, the knowledge remains superficial. Although rarely performed,&#xD;
      there is no doubt that thousands of patients' lives were saved because of the use of arterial&#xD;
      grafts. However, arterial grafts are known to be associated with a higher rate of occlusion&#xD;
      and a lower patient and graft survival when compared to conventional end-to-end anastomosis.&#xD;
      In our recent retrospective study, the investigators showed that retransplantation procedure&#xD;
      and aspirin in patients' medication are independent risk factors for the need of an arterial&#xD;
      conduit. The investigators assume that aspirin could be a surrogate marker for vascular and&#xD;
      metabolic status. Furthermore, in a meta-analysis the investigators found a four times higher&#xD;
      occlusion rate compared to non-conduits.&#xD;
&#xD;
      Whether the site of conduit placement or certain types of material have an impact on&#xD;
      occlusion and graft survival remains unknown. In addition, several studies discuss that&#xD;
      antiaggregation or anticoagulation might be protective for occlusion of arterial conduits.&#xD;
      Currently, there is no study that investigated this problem, most probably because of low&#xD;
      case numbers.&#xD;
&#xD;
      STUDY OBJECTIVES&#xD;
&#xD;
      The primary goal of this study is to conduct a multicenter cohort analysis to define the&#xD;
      outcome of different types of conduits and to investigate whether antiplatelet /&#xD;
      anticoagulantion has an impact on patency rates.&#xD;
&#xD;
        1. Specific aim #1: To identify independent risk factors for early and late occlusion of&#xD;
           arterial conduits in liver transplantation.&#xD;
&#xD;
        2. Specific aim #2: To compare different placement sites (infrarenal, supraceliac, iliacal,&#xD;
           etc.) of arterial conduits in terms of occlusion rates and graft survival.&#xD;
&#xD;
        3. Specific aim #3: To investigate whether antiplatelet therapy is protective in terms of&#xD;
           arterial patency.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      This will be a multicenter single cohort study including only cases of deceased donor liver&#xD;
      transplantation that required an aorto-hepatic or iliac-hepatic conduit for arterial&#xD;
      reconstruction. Primary endpoint is 30-day conduit patency. Secondary endpoints include&#xD;
      postoperative complications, death, late conduit occlusion, graft and patient survival.&#xD;
&#xD;
      SETTING&#xD;
&#xD;
      This multicenter cohort study will include several high-volume centers worldwide. Each&#xD;
      participating center requires a prospective database from that data can be extracted. All&#xD;
      consecutive cases of deceased donor liver transplantation requiring an arterial conduit from&#xD;
      1st of January 2007 until 31st of December 2016 are included allowing a minimum follow-up&#xD;
      time of 6 months. Data collection at conduit4olt.org will be prospective, structured,&#xD;
      anonymized, and encrypted.&#xD;
&#xD;
      INSTITUTIONAL REVIEW POLICY / ETHICAL POLICY&#xD;
&#xD;
      Each participating center is responsible to contact their local ethics committee and receive&#xD;
      approval for participation, if applicable. For example, this project is considered as an&#xD;
      audit in some countries and thus there is no need for formal approval in the form of a&#xD;
      protocol submission.&#xD;
&#xD;
      ELIGIBILITY CRITERIA&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits&#xD;
&#xD;
        -  Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)&#xD;
&#xD;
        -  Whole organ as well as split allografts&#xD;
&#xD;
        -  Primary liver transplantation as well as liver retransplantation&#xD;
&#xD;
        -  Recipient age ≥18 years&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Living donor liver transplantation&#xD;
&#xD;
        -  Pediatric liver transplantation (recipient age &lt;18 years)&#xD;
&#xD;
        -  Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits&#xD;
&#xD;
        -  Multivisceral transplantations&#xD;
&#xD;
      ESTIMATED SAMPLE SIZE&#xD;
&#xD;
      Each center should provide at least 30 cases that meet the inclusion criteria to allow&#xD;
      adequate event rates for each outcome.&#xD;
&#xD;
      Statistical methods&#xD;
&#xD;
      The primary and secondary endpoints will be compared with patient and operation&#xD;
      characteristics with univariate analysis. ROC Curve analysis will be performed to dichotomize&#xD;
      continuous variables. Multivariable analysis (binary logistic and Cox regression) will be&#xD;
      performed to identify independent risk factors. Statistical analysis will be performed using&#xD;
      R Studio version 1.0.44 (RStudio, Inc. GNU Affero General Public License v3, Boston, MA,&#xD;
      2016) with the graphical user interface rBiostatistics.com beta version (rBiostatistics.com,&#xD;
      Zurich, Switzerland, 2016, GNU License).&#xD;
&#xD;
      Christian E. Oberkofler Tim Reese Dimitri A. Raptis Henrik Petrowsky&#xD;
&#xD;
      On behalf of the conduit4olt.org team Swiss HPB Center, Department of Surgery and&#xD;
      Transplantation, University Hospital Zurich, Switzerland&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2018</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Independent risk factors</measure>
    <time_frame>June 2007 til 31st December 2016</time_frame>
    <description>To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placement sites</measure>
    <time_frame>June 2007 til 31st December 2016</time_frame>
    <description>To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patency Rates</measure>
    <time_frame>June 2007 til 31st December 2016</time_frame>
    <description>To investigate whether antiplatelet therapy is protective in terms of arterial patency.</description>
  </primary_outcome>
  <enrollment type="Actual">567</enrollment>
  <condition>Aortohepatic Conduit</condition>
  <condition>Patency Rate</condition>
  <condition>Liver Transplantation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aortohepatic Conduit</intervention_name>
    <description>Placement of an interposition graft between hepatic artery and aorta during liver transplantation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who recieved an aorto-hepatic conduit during liver transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits&#xD;
&#xD;
          -  Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)&#xD;
&#xD;
          -  Whole organ as well as split allografts&#xD;
&#xD;
          -  Primary liver transplantation as well as liver retransplantation&#xD;
&#xD;
          -  Recipient age ≥18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Living donor liver transplantation&#xD;
&#xD;
          -  Pediatric liver transplantation (recipient age &lt;18 years)&#xD;
&#xD;
          -  Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits&#xD;
&#xD;
          -  Multivisceral transplantations&#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>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all collected IPD, all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_url>http://conduit4olt.org</ipd_url>
  </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/NCT03275883
org study id: 2016-01889
nct id: NCT03275883
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the risk profile of hepatic artery occlusion in liver
      transplant recipients who received an aortohepatic conduits, analyzing all consecutive
      cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will
      be examined and adverse events will be analyzed and categorized using the Clavien-Dindo
      classification and Comprehensive Complication Index.
BACKGROUND

      Arterial conduits in liver transplantation are almost as old as the procedure itself. First
      described by Starzl in 1984, the knowledge remains superficial. Although rarely performed,
      there is no doubt that thousands of patients' lives were saved because of the use of arterial
      grafts. However, arterial grafts are known to be associated with a higher rate of occlusion
      and a lower patient and graft survival when compared to conventional end-to-end anastomosis.
      In our recent retrospective study, the investigators showed that retransplantation procedure
      and aspirin in patients' medication are independent risk factors for the need of an arterial
      conduit. The investigators assume that aspirin could be a surrogate marker for vascular and
      metabolic status. Furthermore, in a meta-analysis the investigators found a four times higher
      occlusion rate compared to non-conduits.

      Whether the site of conduit placement or certain types of material have an impact on
      occlusion and graft survival remains unknown. In addition, several studies discuss that
      antiaggregation or anticoagulation might be protective for occlusion of arterial conduits.
      Currently, there is no study that investigated this problem, most probably because of low
      case numbers.

      STUDY OBJECTIVES

      The primary goal of this study is to conduct a multicenter cohort analysis to define the
      outcome of different types of conduits and to investigate whether antiplatelet /
      anticoagulantion has an impact on patency rates.

        1. Specific aim #1: To identify independent risk factors for early and late occlusion of
           arterial conduits in liver transplantation.

        2. Specific aim #2: To compare different placement sites (infrarenal, supraceliac, iliacal,
           etc.) of arterial conduits in terms of occlusion rates and graft survival.

        3. Specific aim #3: To investigate whether antiplatelet therapy is protective in terms of
           arterial patency.

      STUDY DESIGN

      This will be a multicenter single cohort study including only cases of deceased donor liver
      transplantation that required an aorto-hepatic or iliac-hepatic conduit for arterial
      reconstruction. Primary endpoint is 30-day conduit patency. Secondary endpoints include
      postoperative complications, death, late conduit occlusion, graft and patient survival.

      SETTING

      This multicenter cohort study will include several high-volume centers worldwide. Each
      participating center requires a prospective database from that data can be extracted. All
      consecutive cases of deceased donor liver transplantation requiring an arterial conduit from
      1st of January 2007 until 31st of December 2016 are included allowing a minimum follow-up
      time of 6 months. Data collection at conduit4olt.org will be prospective, structured,
      anonymized, and encrypted.

      INSTITUTIONAL REVIEW POLICY / ETHICAL POLICY

      Each participating center is responsible to contact their local ethics committee and receive
      approval for participation, if applicable. For example, this project is considered as an
      audit in some countries and thus there is no need for formal approval in the form of a
      protocol submission.

      ELIGIBILITY CRITERIA

      Inclusion criteria:

        -  Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits

        -  Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)

        -  Whole organ as well as split allografts

        -  Primary liver transplantation as well as liver retransplantation

        -  Recipient age ≥18 years

      Exclusion criteria:

        -  Living donor liver transplantation

        -  Pediatric liver transplantation (recipient age <18 years)

        -  Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits

        -  Multivisceral transplantations

      ESTIMATED SAMPLE SIZE

      Each center should provide at least 30 cases that meet the inclusion criteria to allow
      adequate event rates for each outcome.

      Statistical methods

      The primary and secondary endpoints will be compared with patient and operation
      characteristics with univariate analysis. ROC Curve analysis will be performed to dichotomize
      continuous variables. Multivariable analysis (binary logistic and Cox regression) will be
      performed to identify independent risk factors. Statistical analysis will be performed using
      R Studio version 1.0.44 (RStudio, Inc. GNU Affero General Public License v3, Boston, MA,
      2016) with the graphical user interface rBiostatistics.com beta version (rBiostatistics.com,
      Zurich, Switzerland, 2016, GNU License).

      Christian E. Oberkofler Tim Reese Dimitri A. Raptis Henrik Petrowsky

      On behalf of the conduit4olt.org team Swiss HPB Center, Department of Surgery and
      Transplantation, University Hospital Zurich, Switzerland
observational model: Cohort
time perspective: Other
measure: Independent risk factors
time frame: June 2007 til 31st December 2016
description: To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.
measure: Placement sites
time frame: June 2007 til 31st December 2016
description: To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival
measure: Patency Rates
time frame: June 2007 til 31st December 2016
description: To investigate whether antiplatelet therapy is protective in terms of arterial patency.
intervention type: Procedure
intervention name: Aortohepatic Conduit
description: Placement of an interposition graft between hepatic artery and aorta during liver transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: Yes
ipd description: all collected IPD, all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd url: http://conduit4olt.org