Percutaneous radiofrequency ablation of renal cancer - interventional procedures consultation document
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Percutaneous radiofrequency ablation of renal cancer
Renal cancer is cancer of the kidney. Percutaneous radiofrequency ablation of renal cancer involves placing one or more electrode-needles through the skin into the kidney. The electrodes are placed within the tumour and produce heat, with the aim of destroying the cancer cells.
The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous radiofrequency ablation of renal cancer 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 percutaneous radiofrequency ablation of renal cancer
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· The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 22/04/2010
Target date for publication of guidance: July 2010
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of percutaneous radiofrequency ablation (RFA) for renal cancer appears adequate in the short and medium term to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit, and provided that patients are followed up in the long term.
1.2 Patient selection for percutaneous RFA for renal cancer should be carried out by a urological cancer multidisciplinary team.
1.3 NICE encourages data collection to provide information about the outcomes of this procedure in the long term. Further research should compare the outcomes of RFA with those of other thermal ablation methods for renal cancer.
2 The procedure
2.1 Indications and current treatments
2.1.1 There are few symptoms in the early stages of renal cancer. Typically, symptoms develop as the disease progresses. The first symptom is often blood in the urine; pain and flank mass are other classic symptoms.
2.1.2 Renal cancer may be diagnosed incidentally on imaging studies or patients may present with symptoms. Conventional treatment for renal cancer is total or partial nephrectomy (open or laparoscopic). One of a range of non-resectional ablative procedures such as cryoablation and radiofrequency ablation may be selected for some smaller tumours.
2.2 Outline of the procedure
2.2.1 Percutaneous RFA for renal cancer is carried out under either local anaesthesia and sedation or general anaesthesia. One or more radiofrequency electrodes are inserted percutaneously into the tumour under imaging guidance. Radiofrequency energy is delivered via the electrode(s) to coagulate and destroy the tumour tissue in the target area. The procedure can be repeated if necessary.
| 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/IP215aoverview. |
2.3 Efficacy
2.3.1 A meta-analysis of 47 studies (non-randomised comparative studies and case series) including a total of 1375 tumours treated by RFA (n = 775) or cryoablation (n = 600) reported local tumour progression (defined as radiographic or pathological evidence of residual disease after initial treatment, regardless of time to recurrence) in 13% (100/775) and 5% (31/600) of tumours respectively at a mean 19-month follow-up (p < 0.001). The meta-analysis reported progression to metastatic disease in 2% (19/775) of tumours treated by RFA and 1% (6/600) of tumours treated by cryoablation (p = not significant).
2.3.2 In a non-randomised comparative study of 233 patients (260 tumours), residual or recurrent tumour on follow-up magnetic resonance imaging (MRI) was reported in 11% (9/81) of tumours treated by percutaneous RFA and 2% (3/179) of tumours treated by laparoscopic cryotherapy (1-year and 3-year median follow-up respectively).
2.3.3 A non-randomised comparative study of 264 patients (301 tumours) reported radiographic success (defined as no evidence of central or nodular enhancement after treatment) in 85% (62/73) of patients treated by percutaneous RFA, and 90% (125/139) of patients treated by laparoscopic cryoablation at 6-month follow-up.
2.3.4 Case series of 151 patients (163 tumours), 104 patients (125 tumours) and 97 patients (105 tumours) reported complete tumour ablation at first RFA treatment in 97% (158/163), 87% (109/125) and 79% (83/105) of tumours respectively (confirmed by contrast-enhanced computed tomography (CT) or MRI scans).
2.3.5 A case series of 31 patients (31 tumours) reported primary treatment failure in 3% (1/31) of patients (patient was retreated with RFA and was disease-free after 76 months of follow-up).
2.3.6 The case series of 151 patients reported a 3-year recurrence-free survival probability of 92% for all patients and 87% for 84 patients with confirmed renal cell carcinoma. The case series of 31 patients reported disease-specific survival of 100%, recurrence-free survival of 89% and overall survival of 63% (all at 80 months).
2.3.7 The Specialist Advisers listed key efficacy outcomes as radiological confirmation of tumour devascularisation, imaging follow-up to confirm tumour involution at 2 and 5 years, and overall and disease-free survival. They indicated that there is uncertainty about the procedure’s efficacy in tumours 4 cm or greater in diameter.
2.4 Safety
2.4.1 Haemorrhage was reported in 6% (5/85) of patients in a case series of 85 patients. Life-threatening haematuria approximately 42 hours after treatment by RFA requiring transcatheter embolisation was described in a case report.
2.4.2 Haematoma requiring blood transfusion was reported in 1% (1/104) of patients in a case series and 1% (1/82) of RFA procedures in the non-randomised comparative study of 233 patients. Haematoma not requiring blood transfusion was reported in 5% (4/82) (3 perirenal requiring no treatment; 1 retroperitoneal) of RFA procedures in the non-randomised comparative study of 233 patients. Asymptomatic perirenal haematoma development was reported in 12% (4/34) (managed conservatively with no sequelae) of RFA procedures in the case series of 31 patients.
2.4.3 Ureteric stricture development was reported after 1% (1/120) of treatments, and in 1% (1/85) and 2% (2/104) of patients in case series of 97, 85 and 104 patients respectively.
2.4.4 Urinoma (a collection of fluid resulting from a urine leak) was reported in 1 patient each in the case series of 97 and 85 patients. Ureteropelvic junction obstruction requiring nephrectomy was described in a case report.
2.4.5 Thermal injury to the duodenum requiring laparotomy was reported in 1 patient in the case series of 97 patients.
2.4.6 Renoduodenal fistula was diagnosed 5 days after the procedure in 1 patient in a case report. CT at 6 months showed that the tumour (a clear cell carcinoma) was growing again and an open nephrectomy was performed.
2.4.7 A case report described that 3 patients (out of a series of 48 patients) developed neuromuscular complications after RFA treatment. One patient developed persistent laxity of flank muscles, whilst the other 2 developed sensory loss and paraesthesia of the lateral abdominal wall (resolved after 3 months).
2.4.8 The Specialist Advisers stated that theoretical adverse events included bowel perforation, perirenal haematoma, pelvicalyceal injury, and pain due to intercostal nerve damage.
3 Further information
3.1 For related NICE guidance see www.nice.org.uk
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2010
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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: 19 August 2015