Microwave ablation for the treatment of liver metastases

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1 Microwave ablation for the treatment of liver Issued: August 2011 guidance.nice.org.uk/ipg NICE has accredited the process used by the NICE Interventional Procedures Programme to produce interventional procedures guidance. Accreditation is valid for 5 years from January 2010 and applies to guidance produced since January 2009 using the processes described in the 'Interventional Procedures Programme: Process guide, January 2009' and the 'Interventional Procedures Programme: Methods guide, June 2007'. More information on accreditation can be viewed at NICE 2011

2 1 Guidance This document replaces previous guidance on microwave ablation for the treatment of in the liver (interventional procedure guidance 220). 1.1 Current evidence on microwave ablation for the treatment of liver raises no major safety concerns. The evidence on efficacy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. 1.2 Clinicians wishing to undertake microwave ablation for the treatment of liver should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients and their carers understand the uncertainty about the procedure's efficacy and provide them with clear written information, including details about other treatment options. In addition, use of NICE's information for patients ('Understanding NICE guidance') is recommended (available from Audit and review clinical outcomes of all patients having microwave ablation for the treatment of liver (see section 3.1). 1.3 Patient selection should be carried out by a hepatobiliary cancer multidisciplinary team. 1.4 NICE encourages further research into microwave ablation for the treatment of liver. Research should clearly define patient selection criteria and report tumour recurrence and patient survival. Comparison with other ablative techniques would be useful. NICE may review the procedure on publication of further evidence. NICE All rights reserved. Last modified August 2011 Page 2 of 5

3 2 The procedure 2.1 Indications and current treatments Liver are commonly caused by colorectal cancer or other malignancies, such as lung and gastric cancer Treatment of liver principally depends on their extent and location. Treatment options include surgical resection, different ablation procedures, systemic chemotherapy, different types of arterial embolisation and external beam radiotherapy. 2.2 Outline of the procedure Microwave ablation aims to destroy tumour cells using heat, resulting in localised areas of tissue necrosis, with minimal morbidity The procedure can be performed with the patient under local or general anaesthesia; either percutaneously or during open or laparoscopic surgery. A needle electrode is advanced into each targeted liver metastasis under image guidance and the lesions are ablated. Multiple pulses of energy may be delivered during one session, and multiple needle electrodes can be used to treat larger tumours Various devices can be used for this procedure. 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 Efficacy A randomised controlled trial (RCT) of 30 patients with multiple colorectal liver treated by microwave ablation or hepatic resection reported mean NICE All rights reserved. Last modified August 2011 Page 3 of 5

4 overall survival of 27 months and 25 months respectively (p = 0.83). In the same study, mean disease-free survival was 11.3 and 13.3 months respectively (p = 0.47). A non-randomised controlled study of 53 patients with multiple bilobar liver treated by resection plus microwave ablation or by resection alone reported 3-year disease-free survival of 17% and 11% respectively (p = 0.54). Survival free of hepatic recurrence was 39% and 35% respectively at 5-year follow-up (p = 0.86). A case series of 74 patients with liver reported mean overall survival of 22.1 months. Disease-free survival was 35% (26/74) at a mean follow-up of 25 months A case series of 100 patients (83 with liver ) reported that complete ablation on postoperative computed tomography (CT) scan was achieved in 98% of patients with colorectal liver, 90% of patients with carcinoid (origin of primary not stated), and 100% of patients with other (absolute figures not stated) The Specialist Advisers listed key efficacy outcomes as disease-free and longterm survival. 2.4 Safety There were no procedure-related deaths following microwave ablation in the RCT of 30 patients, in 2 non-randomised controlled studies of 53 and 19 patients, and in 3 case series of 160, 100 and 87 patients The non-randomised controlled study of 53 patients reported biliary fistula formation (not otherwise described) in 1 out of 37 patients who had combined resection and microwave ablation, and in 1 out of 16 patients who had resection alone (significance and follow-up not stated) Pleural effusion was reported in 2% (4/257) of patients and 9% (14/160) of patients (1 requiring drainage) in case series of 1136 patients (257 with ) and 160 patients (63 with liver ) respectively (follow-up not stated). The case series of 74 patients reported minor to moderate pleural effusion in 9% (7/74) of patients (mean follow-up 25 months). NICE All rights reserved. Last modified August 2011 Page 4 of 5

5 2.4.4 The case series of 87 patients reported pain requiring termination of the microwave ablation procedure in 1 patient The Specialist Advisers listed anecdotal or reported adverse events as abscess, bleeding, infection, pneumothorax, colonic perforation, fever, tumour seeding, and bile duct injury. They considered theoretical adverse events to include deterioration in liver function and adjacent organ damage to the kidney, lung or heart. 2.5 Other comments The Committee noted that technical developments have been made in this procedure; in particular, narrower probes are now available. 3 Further information 3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion), available from For related NICE guidance see Information for patients NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind. See NICE All rights reserved. Last modified August 2011 Page 5 of 5

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