The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection (LIVER 3)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Edinburgh, United Kingdom
- NHS Lothian
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Local Anaesthetic Wound Infiltration
Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection
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Resection of diseased liver
|
|
Active Comparator: Epidural
Conventional practice following liver resection
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Resection of diseased liver
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival in months
Time Frame: 5 years
|
Number of months from the date of surgery to the date of death or the censor date
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: 3 years
|
Number of months from the date of surgery to the date of death or the censor date
|
3 years
|
|
Disease free survival
Time Frame: 5 years
|
Number of months from the date of surgery to the date of disease recurrence or the censor date
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Hughes, NHS Lothian
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 258352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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