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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: Liver resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Long term follow up of previously randomised populations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Anaesthetic Wound Infiltration<br>Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection | Procedure: Liver resection<br>* Resection of diseased liver<br>|
| Active Comparator: Epidural<br>Conventional practice following liver resection | Procedure: Liver resection<br>* Resection of diseased liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in months | 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 | Number of months from the date of surgery to the date of death or the censor date | 3 years | 
| Disease free survival | Number of months from the date of surgery to the date of disease recurrence or the censor date | 5 years |