The National Institute for Clinical Excellence is examining radiofrequency ablation of liver tumours and will publish guidance on its safety and efficacy for the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about radiofrequency ablation of liver tumours.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 28 April 2003
Target date for publication of guidance: 23 July 2003

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation

Provisional recommendations

The Committee decided that the guidance on radiofrequency ablation (RFA) should be specific to the two indications:

• hepatocellular carcinoma
• colorectal cancer metastases.

Hepatocellular carcinoma

Current evidence of the safety and efficacy of RFA for hepatocellular carcinoma appears adequate to support use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

The Committee also recommended that:

• patient selection is very important and should be carried out by a multidisciplinary team that includes a hepatobiliary surgeon
• the procedure should be monitored by CT or ultrasound.

Colorectal cancer metastases

Current evidence of the safety and efficacy of RFA for colorectal cancer metastases does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake RFA of colorectal cancer metastases should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and that appropriate arrangements are in place for clinical audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

As a randomised controlled trial, Chemotherapy and Local ablation versus Chemotherapy (CLOCC), is already under way, NICE will not refer the procedure to the Review Body for further investigation at present. Patients with liver metastases should be considered for inclusion in the CLOCC trial.

The procedure

Indications

Hepatocellular carcinoma and metastases from colorectal carcinoma are the two most common malignant tumours affecting the liver. The majority of malignant liver tumours are unsuitable for surgical excision because of their number, distribution and/or the presence of residual disease elsewhere. Therefore, a number of alternative treatments have been developed, of which RFA is one.

Outline of the procedure

RFA is a recently developed minimally invasive technique which destroys tissue by heating. Electrodes are inserted percutaneously into the tumour and current is applied to generate local heating and destroy tissue.

There is evidence that RFA results in destruction of tumour, which may be associated with higher survival rates. Most of this evidence is reported in patients with hepatocellular carcinoma

Safety

Complications of RFA are not common, but include hepatic abscess and injury to bile ducts. The rate of complications appears lower than that with alternative treatments.

Experts suggest a mortality of lower - perhaps much lower - than 8%. The complication rate is believed to be 3-5%.

Other comments

The Committee noted that little evidence is available about the safety and efficacy of RFA in treatment of colorectal metastases.