Ablation versus surgery for colorectal liver metastases - a clinical trial
A new Clinical Trial led by Royal Free Hospital comparing treatment plans for patients with colorectal liver metastases.
(National Institute of Health Research HTA: 13/153/04)
The Clinical Problem
33,000 people develop bowel cancer each year in England. It is more common in the elderly. About 30% of these patients have bowel cancer which spreads to the liver (colorectal liver metastases) within 5 years of detection and treatment of the original 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.
Treatment through Liver Resection Surgery
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.
Treatment through Ablative Methods
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. There is also concern from the limited data available that the cure rate after ablation may be lower compared with surgery.
The Clinical Trial
Because of uncertainty as to the best treatment for these high risk patients, Prof Brian Davidson and Dr Kurinchi Gurusamy are conducting an international, multicentre trial that 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 15 centres in UK and 5 centres in The Netherlands with experts in liver surgery and ablation therapy. 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. All regulatory approvals have been obtained for this trial and the trial will start recruiting in October 2016.