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Completed

NCT Number: NCT03813953

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian

Edinburgh, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liver resection

Procedure

Resection of diseased liver

Primary outcomes

  1. 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

Secondary outcomes

  1. overall survival

    Time frame: 3 years

    Number of months from the date of surgery to the date of death or the censor date

  2. 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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Acronym: LIVER 3

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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