<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/NCT03813953</url>
  </required_header>
  <id_info>
    <org_study_id>258352</org_study_id>
    <nct_id>NCT03813953</nct_id>
  </id_info>
  <brief_title>The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection</brief_title>
  <acronym>LIVER 3</acronym>
  <official_title>The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Edinburgh</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 LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local&#xD;
      Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled&#xD;
      trials that compared epidural analgesia with local anaesthetic wound infiltration as&#xD;
      post-operative analgesia in patients undergoing open liver resection.&#xD;
&#xD;
      The overall findings of this trial were of similar rates of morbidity and pain control&#xD;
      post-operatively but a reduced recovery time for the wound catheter group. As a result, wound&#xD;
      catheter local anesthetic infiltration has become increasingly utilized in this unit and&#xD;
      within other units throughout the country and worldwide.&#xD;
&#xD;
      Epidural use has been associated with improved long term outcomes following abdominal cancer&#xD;
      surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials&#xD;
      to assess survival between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LIVER and LIVER 2 studies were randomised controlled trials that compared epidural&#xD;
      analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients&#xD;
      undergoing open liver resection.&#xD;
&#xD;
      The overall findings of this trial were of similar rates of morbidity and pain control&#xD;
      post-operatively but a reduced recovery time for the wound catheter group. As a result, wound&#xD;
      catheter local anesthetic infiltration has become increasingly utilized in this unit and&#xD;
      within other units throughout the country and worldwide.&#xD;
&#xD;
      There has been some evidence however, that epidural analgesia post-operatively can have a&#xD;
      positive impact on long term survival in patients undergoing abdominal surgery for cancer.&#xD;
      The reasons for this are not well established but it is proposed that the protective effect&#xD;
      against the immunosuppression following major surgery that epidural has can aid in the cancer&#xD;
      prevention process. There remains no randomised controlled trials looking at this subject in&#xD;
      open liver surgery.&#xD;
&#xD;
      The aim of this study is to assess the overall and disease free survival of the patients who&#xD;
      participated in the LIVER and LIVER 2 trials.&#xD;
&#xD;
      The primary outcome is 5 year overall survival. Data will be observed from electronic (or non&#xD;
      electronic) patient records, information and statistics department data and general practice&#xD;
      records as required.&#xD;
&#xD;
      Overall survival at 1 and 3 years Disease free survival at 1, 3 and 5 years (Data will be&#xD;
      observed from Lothian hepatobiliary multi-disciplinary team meeting data and follow up CT/MRI&#xD;
      scan dates)&#xD;
&#xD;
      Median overall and disease free survival Survival according to individual pathology&#xD;
      subgroups.&#xD;
&#xD;
      Participants will be identified from study records of the LIVER and LIVER 2 trials. This will&#xD;
      be performed by the two study investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">June 16, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Long term follow up of previously randomised populations.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival in months</measure>
    <time_frame>5 years</time_frame>
    <description>Number of months from the date of surgery to the date of death or the censor date</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Number of months from the date of surgery to the date of death or the censor date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Number of months from the date of surgery to the date of disease recurrence or the censor date</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>Local Anaesthetic Wound Infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional practice following liver resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver resection</intervention_name>
    <description>Resection of diseased liver</description>
    <arm_group_label>Epidural</arm_group_label>
    <arm_group_label>Local Anaesthetic Wound Infiltration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a&#xD;
             malignancy and underwent liver resection for this malignancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had liver resection for benign disease. Patients who participated in the&#xD;
             LIVER/LIVER2 trials but who did not undergo resection.&#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>Michael Hughes</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lothian</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael J Hughes, FRCS</last_name>
    <phone>07734429759</phone>
    <email>michaelh@doctors.net.uk</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</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>Liver Neoplasms</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/NCT03813953
org study id: 258352
nct id: NCT03813953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local
      Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled
      trials that compared epidural analgesia with local anaesthetic wound infiltration as
      post-operative analgesia in patients undergoing open liver resection.

      The overall findings of this trial were of similar rates of morbidity and pain control
      post-operatively but a reduced recovery time for the wound catheter group. As a result, wound
      catheter local anesthetic infiltration has become increasingly utilized in this unit and
      within other units throughout the country and worldwide.

      Epidural use has been associated with improved long term outcomes following abdominal cancer
      surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials
      to assess survival between the two groups.
The LIVER and LIVER 2 studies were randomised controlled trials that compared epidural
      analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients
      undergoing open liver resection.

      The overall findings of this trial were of similar rates of morbidity and pain control
      post-operatively but a reduced recovery time for the wound catheter group. As a result, wound
      catheter local anesthetic infiltration has become increasingly utilized in this unit and
      within other units throughout the country and worldwide.

      There has been some evidence however, that epidural analgesia post-operatively can have a
      positive impact on long term survival in patients undergoing abdominal surgery for cancer.
      The reasons for this are not well established but it is proposed that the protective effect
      against the immunosuppression following major surgery that epidural has can aid in the cancer
      prevention process. There remains no randomised controlled trials looking at this subject in
      open liver surgery.

      The aim of this study is to assess the overall and disease free survival of the patients who
      participated in the LIVER and LIVER 2 trials.

      The primary outcome is 5 year overall survival. Data will be observed from electronic (or non
      electronic) patient records, information and statistics department data and general practice
      records as required.

      Overall survival at 1 and 3 years Disease free survival at 1, 3 and 5 years (Data will be
      observed from Lothian hepatobiliary multi-disciplinary team meeting data and follow up CT/MRI
      scan dates)

      Median overall and disease free survival Survival according to individual pathology
      subgroups.

      Participants will be identified from study records of the LIVER and LIVER 2 trials. This will
      be performed by the two study investigators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Long term follow up of previously randomised populations.
primary purpose: Other
masking: None (Open Label)
measure: Overall survival in months
time frame: 5 years
description: Number of months from the date of surgery to the date of death or the censor date
measure: overall survival
time frame: 3 years
description: Number of months from the date of surgery to the date of death or the censor date
measure: Disease free survival
time frame: 5 years
description: Number of months from the date of surgery to the date of disease recurrence or the censor date
arm group label: Local Anaesthetic Wound Infiltration
arm group type: Experimental
description: Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection
arm group label: Epidural
arm group type: Active Comparator
description: Conventional practice following liver resection
intervention type: Procedure
intervention name: Liver resection
description: Resection of diseased liver
arm group label: Epidural
arm group label: Local Anaesthetic Wound Infiltration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Hughes
role: Principal Investigator
affiliation: NHS Lothian
last name: Michael J Hughes, FRCS
phone: 07734429759
email: michaelh@doctors.net.uk
responsible party type: Sponsor
mesh term: Liver Neoplasms
sharing ipd: No