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The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection (LIVER 3)

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Liver resection
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a malignancy and underwent liver resection for this malignancy.

Exclusion Criteria:

  • Patients who had liver resection for benign disease. Patients who participated in the LIVER/LIVER2 trials but who did not undergo resection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Local Anaesthetic Wound Infiltration

    Epidural

    Arm Description

    Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection

    Conventional practice following liver resection

    Outcomes

    Primary Outcome Measures

    Overall survival in months
    Number of months from the date of surgery to the date of death or the censor date

    Secondary Outcome Measures

    overall survival
    Number of months from the date of surgery to the date of death or the censor date
    Disease free survival
    Number of months from the date of surgery to the date of disease recurrence or the censor date

    Full Information

    First Posted
    December 10, 2018
    Last Updated
    January 21, 2019
    Sponsor
    University of Edinburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813953
    Brief Title
    The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection
    Acronym
    LIVER 3
    Official Title
    The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 20, 2019 (Anticipated)
    Primary Completion Date
    May 31, 2019 (Anticipated)
    Study Completion Date
    June 16, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Edinburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Long term follow up of previously randomised populations.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Local Anaesthetic Wound Infiltration
    Arm Type
    Experimental
    Arm Description
    Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection
    Arm Title
    Epidural
    Arm Type
    Active Comparator
    Arm Description
    Conventional practice following liver resection
    Intervention Type
    Procedure
    Intervention Name(s)
    Liver resection
    Intervention Description
    Resection of diseased liver
    Primary Outcome Measure Information:
    Title
    Overall survival in months
    Description
    Number of months from the date of surgery to the date of death or the censor date
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    overall survival
    Description
    Number of months from the date of surgery to the date of death or the censor date
    Time Frame
    3 years
    Title
    Disease free survival
    Description
    Number of months from the date of surgery to the date of disease recurrence or the censor date
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a malignancy and underwent liver resection for this malignancy. Exclusion Criteria: Patients who had liver resection for benign disease. Patients who participated in the LIVER/LIVER2 trials but who did not undergo resection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael J Hughes, FRCS
    Phone
    07734429759
    Email
    michaelh@doctors.net.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Hughes
    Organizational Affiliation
    NHS Lothian
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection

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