LAVA- Liver resection surgery versus thermal ablation for CLM
Research type
Research Study
Full title
LAVA- Liver Resection Surgery Versus Thermal Ablation for Colorectal LiVer MetAstases
IRAS ID
193773
Contact name
Suzanne Emerton
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN52040363
Clinicaltrials.gov Identifier
Z6364106/2015/11/17 , UCL Data Protection Registration
Duration of Study in the UK
9 years, 10 months, 30 days
Research summary
About 30% of people have bowel cancer spread to the liver (colorectal liver metastases) within 5 years of detection and treatment of bowel cancer. Partial removal of the liver (liver resection) is effective in improving the life expectancy in people with colorectal liver metastases (CLM). However, only about 7% to 20% of people with colorectal liver metastases undergo liver resections because of the age and general fitness (comorbidities) of the patient or because of the extent of cancer spread. Liver resection is a major operation with high complication rates. At present, liver resection is the standard treatment in people below 70 years of age who are otherwise well with cancer confined to the liver and with limited involvement of the liver. However the treatment of elderly people (age above 75 years), those with additional medical problems (such as severe heart or lung disease) and those in whom there is extensive spread to multiple sites within the liver (high risk patients) is less clear. Some surgeons offer liver resection surgery to these high risk patients with the belief that surgery is the only chance of cure in such patients while others do not offer surgery because they do not believe it is justified when risks are great and the chance of cure is small. Ablative treatments (destruction of cancer using methods other than surgery) offer an alternative to surgery in patients with colorectal liver metastases. Thermal ablation destroys the liver cancers using a needle that heats the cancer deposits until they are destroyed. They have been used for many years in the treatment of patients with liver metastases but their benefits remain unclear. The ablation can be carried out by a needle passed into the liver through the skin without any surgery (percutaneous ablation). There is significant controversy as to whether ablation offers equivalent survival compared to surgery. Two methods of thermal ablation are in current practice, radiofrequency ablation (RFA) and microwave ablation (MWA). At present, there is no strong evidence favouring one method of thermal ablation over another. Because of uncertainty as to the best treatment for these high risk patients, this trial will compare the outcome of thermal ablation and liver resection surgery. Patients suitable for either surgery or ablation but considered high risk would be offered one or other on the basis of chance (a randomised trial). The treatment will be performed in centres with experts in liver surgery and ablation therapy. All patients will be followed up carefully to look for any recurrence of the cancer. If further cancer deposits were detected the patients will not be restricted in any way as to the subsequent treatment which can be given. The trial will include patients from all over the UK and in Holland over a period of 4 years. Analysis will be carried out after a minimum follow up period of two years. The trial outcome should allow us to determine which treatment is most effective and provides best value for money in high risk patients with colorectal liver metastases. The best treatment can then be offered to all high risk patients with colorectal liver metastases throughout the NHS. The results may have implications for the management of other patient groups with colorectal metastases.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/0058
Date of REC Opinion
5 Feb 2016
REC opinion
Further Information Favourable Opinion