Image-guided radiofrequency excision biopsy of breast lesions (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

 

Interventional procedure consultation document

 

Interventional procedure overview of image-guided radiofrequency excision biopsy of breast lesions

 

Breast lumps may need to be sampled to test for cancer. This minimally invasive procedure involves a small incision and insertion of a probe which uses radiofrequency energy to cut through the breast internally, aiming to remove the lump along with a small area of surrounding tissue to test for cancer.

 

The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of image-guided radiofrequency excision biopsy of breast lesionsand 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 image-guided radiofrequency excision biopsy of breast lesions.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 24 April 2009

Target date for publication of guidance: July 2009

 

1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of image-guided radiofrequency (RF) excision biopsy of breast lesions is inadequate in quantity and quality, and there are concerns about the possibility of false-negative biopsy results. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2

Clinicians wishing to undertake image-guided RF excision biopsy of breast lesions 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 safety and efficacy. They should provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having image-guided RF excision biopsy of breast lesions (see section 3.1).
1.3 NICE encourages further research into image-guided RF excision biopsy of breast lesions. Research should be in the form of diagnostic studies aimed at quantifying the risk of false-negative results associated with the procedure. NICE may review the procedure on publication of further evidence.
2 The procedure
2.1 Indications and current treatments
2.1.1 Breast cancer is the most common cancer in women in the UK. It can be categorised into four stages, from stage 1 (an isolated tumour less than 2 cm in diameter) to stage 4 (advanced cancer), and three grades, from grade 1 (slow-growing cancer) to grade 4 (fast-growing cancer).
2.1.2 Ductal carcinoma in situ (DCIS) is a very early form of non-invasive breast cancer and, if left untreated, may develop into an invasive cancer, such as invasive ductal carcinoma (IDC). Fibroadenomas are benign tumours, typically between 1 cm and 3 cm in size.
2.1.3 Diagnosis of whether a tumour is malignant or benign isusually based on both imaging and tissue examination, often by cytology of cells recovered through fine needle aspiration. Open surgical biopsy or image-guided vacuum-assisted core biopsy can also be used.
2.1.4 If cancer is diagnosed, treatment depends on the type, stage and grade of the tumour. Surgery is often the first option and may involve removing part of the breast (‘conservative’ or ‘breast-conserving’ surgery) or the whole breast (mastectomy).
2.2 Outline of the procedure
2.2.1 The aim of image-guided RF excision biopsy of breast lesions is to deliver an intact specimen for histological examination, while minimising the risk of bleeding and haematoma formation.
2.2.2 The procedure is carried out with the patient under local anaesthesia. Using image guidance, a small incision is made in the breast at the subcutaneous tissue level. A probe with a unipolar RF cutting tip is advanced to the site of the lesion. Small wires and capturing arms are extended from the tip of the probe to surround the lesion, which is then dissected using the RF cutting tip. The sample is captured in the arms of the device and withdrawn.
2.2.3 Probes of various diameters and expandable RF cutting tips can be used, depending on the diameter of the sample to be captured.
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/IP741overview.

 

2.3 Efficacy
2.3.1 In a case series of 742 breast lesions (absolute number of patients not reported), 34 lesions were initially identified as atypical ductal hyperplasia (ADH) (benign lesions) after RF excision biopsy. Following subsequent surgery and histological examination 9% (3/34) of the lesions were false negatives; they were subsequently diagnosed as either DCIS or invasive ductal carcinoma. Similarly, 5% (6/119) of lesions initially diagnosed as DCIS following RF excision biopsy were subsequently diagnosed asinvasive ductal carcinoma after surgical excision and biopsy.
2.3.2 In a case series of 100 patients (106 lesions) with breast lesions diagnosed as fibroadenomas based on imaging findings who were subsequently evaluated by RF excision biopsy, 93% (79/85) of patients showed no physical or imaging evidence of residual lesions at follow-ups of between 4 and 6 months.
2.3.3 The Specialist Advisers stated that the key efficacy outcomes for this procedure, when used for benign lesions, included intact removal of the lesion and patient acceptability/cosmetic appearance. The Specialist Advisers considered that additional efficacy outcomes, when used in early breast cancer, included delivery of an evaluable lesion for histology; and both local recurrence and survival.
2.4 Safety
2.4.1 The case series of 742 lesions (absolute number of patients not reported) reported that infection (not otherwise defined) occurred in less than 1% (1/742) of biopsies (resolved with oral antibiotics) (follow-up not stated). The case series of 100 patients (106 lesions) recorded a mean pain score during the procedure of less than 1 point (using a visual analogue scale from 0 [no pain] to 10 [most severe pain]).
2.4.2 In the case series of 100 patients (106 lesions), bleeding occurred in 2% (1/106) of excision procedures but this was controlled by ‘conservative measures’ (not otherwise defined).
2.4.3 The Specialist Advisers listed adverse events reported in the literature including haematoma, infection, skin burns and failure to retrieve a specimen. They considered theoretical adverse events to include seeding of tumour cells along the biopsy tract, haemorrhage, pain (temporary), failure to deliver an adequate sample and fat necrosis due to thermal damage.
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 is developing audit support (which is for use at local discretion), which will be available when the guidance is published.
3.2 NICE has published interventional procedures guidance on image Image-guided vacuum-assisted excision biopsy of benign breast lesions (www.nice.org.uk/IPG156). In addition, NICE has published cancer service guidance, interventional procedures guidance, technology appraisals guidance and clinical guidelines on breast cancer. For more information see www.nice.org.uk/Guidance/Topic.

 

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

December, 2008

Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.

 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