Radiofrequency ablation for the treatment of colorectal metastases in the liver (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Radiofrequency ablation for the treatment of colorectal liver metastases
Colorectal cancer is a type of cancer that develops in the bowel (including the colon and rectum). In some patients, cancer cells could spread from the bowel to other parts of the body to form one or more ‘secondary tumours’, also known as ‘metastases’. For bowel cancer, most commonly secondary tumours occur in the liver.
Radiofrequency ablation uses heat to destroy cancer cells in the liver. It involves placing one or more electrodes into the tumour. The electrodes are used to heat the tumour with the aim of destroying it. Radiofrequency ablation can be applied through the skin or during surgery.
The National Institute for Health and Clinical Excellence (NICE) is examining radiofrequency ablation for the treatment of colorectal liver metastases and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about radiofrequency ablation for the treatment of colorectal liver metastases.
This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
- comments on the provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE 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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 20 August 2009
Target date for publication of guidance: November 2009
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of radiofrequency (RF) ablation for the treatment of colorectal liver metastases is adequate to support the use of this procedure in patients unfit or otherwise unsuitable for hepatic resection, or in those who have previously had hepatic resection, provided that normal arrangements are in place for clinical governance, consent and audit.
1.2 Patient selection should be carried out by a multidisciplinary team that includes a hepatobiliary surgeon, a radiologist and an oncologist.
2 The procedure
2.1 Indications and current treatments
2.1.1 Colorectal cancer is the second most common cancer in women and the third most common cancer in men in the UK. The liver is the most common site for metastases.
2.1.2 Treatment for patients with liver metastases from colorectal cancer is usually palliative. However, for a minority of patients, liver resection with curative intent may be possible, depending on the number, location and size of the metastases. Other treatment options include systemic chemotherapy, radiotherapy, cryotherapy, arterial embolisation with chemotherapeutic agents or alcohol, selective internal radiation therapy and laser photocoagulation.
2.2 Outline of the procedure
2.2.1 A percutaneous or intraoperative approach may be used, with the patient under appropriate local or general anaesthesia. Needle electrodes are inserted into the target tumour area (or areas) using ultrasound guidance. A high-frequency alternating current is applied resulting in heat generation, which causes localised coagulative necrosis and tissue destruction around the electrodes.
2.2.2 Several different types of RF electrodes are available.
| Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP248aoverview |
2.3 Efficacy
2.3.1 A non-randomised controlled trial of 46 patients treated by RF ablation or surgical resection described in a systematic review reported that median survival after diagnosis of liver metastases was 44 and 54 months, respectively (significance not stated). In the same systematic review, 6 case series reported survival ranging from 17% (1/6) at 11-month follow-up to 88% (7/8) at 2- to 6- month follow-up. A non-randomised controlled trial of 418 patients reported that patients treated by surgical resection had overall survival rates of 73%, 65% and 58% at 3, 4 and 5- year follow-up, respectively - significantly higher than patients treated by RF ablation alone, or by RF ablation plus resection (absolute figures not stated) (p < 0.0001). In the same study, the difference in survival between patients treated by RF ablation alone and RF ablation plus surgical resection was not statistically significant (p = 0.36). A non-randomised controlled trial of 258 patients reported that 3-year disease-free survival was significantly greater in patients treated by surgical resection alone (40%) than in those treated by RF ablation plus resection (34%) (absolute figures not stated) (p = 0.01).
2.3.2 A case series of 243 patients with unresectable metastases (defined in the paper as a poor response to chemotherapy or comorbidity limiting surgical excision) reported survival rates of 20.2% and 18.4% at 3- and 5-year follow-up, respectively (absolute figures not stated).
2.3.3 The non-randomised controlled trial of 418 patients reported that recurrence at any site occurred more often in the RF ablation group (84%) than in the surgical resection group (52%) at a median 21-month follow-up (absolute figures not stated) (p < 0.001). The non-randomised controlled trial of 258 patients reported that recurrence at any site at 1-year follow-up was significantly lower in the surgical resection group (24%) than in the RF ablation plus resection group (61%) or the RF ablation alone group (66%) (absolute figures not stated) (p < 0.001). A case series of 161 patients treated by laparoscopic RF ablation reported that local recurrence occurred in 37% (124/335) of patients at a mean follow‑up of 17 months.
2.3.4 The Specialist Advisers listed key efficacy outcomes as overall survival and local recurrence rate.
2.4 Safety
2.4.1 Three cases series described in the systematic review reported postoperative complication rates between 0% and 33% including bowel perforation, peritoneal seeding (metastasis), bile duct stricture, wound infection and postoperative bleeding (absolute figures not stated).
2.4.2 A case series of 122 patients reported infected biloma development (requiring percutaneous drainage) in 1% (1/122) of patients, and biliary dilation and cholangitis leading to biliobronchial fistula in 1% (1/122) of patients. Minor complications (not requiring intervention) included development of a small haemoperitoneum in 2% (3/122), biliary dilation in 3% (4/122) and persistent pain (location not reported) in 2% (3/122) of patients.
2.4.3 A case report of a patient previously treated by both surgical resection and cryoablation described cutaneous fistula formation between the site of electrode insertion and the gastric antrum at 3-week follow-up. This had resolved at 6-month follow-up.
2.4.4 Another case report described a patient with pain and fever (40°C) at 5-day follow-up. Abdominal ultrasound revealed an intrahepatic abscess which required drainage. The patient recovered uneventfully.
2.4.5 The Specialist Advisers listed anecdotal adverse events as damage to the biliary tree and bradycardia. They considered theoretical adverse events to include injury to the bowel or diaphragm and damage to the pleura or lungs.
2.5 Other comments
2.5.1 The Committee noted that the evidence was difficult to interpret because patient selection criteria and the use of concomitant treatments differed between the studies.
3 Further information
3.1 This document is a review of the NICE interventional procedure guidance 92 published in 2004.
3.2 For related NICE guidance see www.nice.org.uk
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2009
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It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 March 2010