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

Liver Cancer Clinical Trial

— LIVER 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813953
• Other study ID #: 258352
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• Liver resection
Resection of diseased liver

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival in months	Number of months from the date of surgery to the date of death or the censor date	5 years
Secondary	overall survival	Number of months from the date of surgery to the date of death or the censor date	3 years
Secondary	Disease free survival	Number of months from the date of surgery to the date of disease recurrence or the censor date	5 years