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
About this trial
This is an interventional other trial for Liver Cancer
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.
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
NCT ID
NCT03813953
First Posted
December 10, 2018
Last Updated
January 21, 2019
Sponsor
University of Edinburgh
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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