Endoscopic mastectomy and endoscopic wide local excision for breast cancer: interventional procedures consultation
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Endoscopic mastectomy (total or partial)
|Treatment for early breast cancer usually involves surgery to remove all or part of the breast. In this keyhole procedure, part or all of the breast tissue is removed using special instruments inserted through small skin incisions. The skin envelope of the breast and nipple are left intact, ready for an implant that can be inserted during the same operation.|
The National Institute for Health and Clinical Excellence (NICE) is examining Endoscopic mastectomy (total or partial) 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 Endoscopic mastectomy (total or partial).
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:
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.
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 We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved.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: 27 January 2009
Target date for publication of guidance: April 2009
|1.1||Current evidence on the safety and efficacy of endoscopic mastectomy and endoscopic wide local excision for breast cancer is inadequate in quantity. Therefore, this procedure should only be used in the context of research. The outcome measures should include safety and efficacy in relation to adequacy of resection margins, survival, recurrence or reoperative rates, tumour size and location, patient breast size, quality of life, and cosmesis.|
|1.2||Research should be conducted only in units specialising in the management of breast cancer, by surgeons trained in both breast cancer surgery and endoscopy.|
|1.3||NICE may review the procedure on publication of further evidence.|
|2.1||Indications and current treatments|
|2.1.1||Breast cancer is the most common cancer in women in theUK. It is categorised into four stages: from stage 1 (an isolated tumour less than 2 cm in diameter) to stage 4 (advanced cancer), and three grades: grade 1 (slow-growing cancer) to grade 4 (fast-growing cancer). It may be further classified into types, depending on whether there are proteins present in the cancer tissue.|
|2.1.2||Treatment depends on the type, stage and grade of the breast cancer. Surgery is often the first option for early breast cancer management and may involve removing the whole breast (mastectomy) or part of the breast (‘conservative' or ‘breast conserving' surgery) in the form of a lumpectomy, wide local excision or segmentectomy. Radiotherapy, chemotherapy or hormone therapy may be administered as an adjuvant to surgery to reduce the risk of local tumour recurrence.|
|2.2||Outline of the procedure|
|2.2.1||Endoscopic mastectomy and endoscopic wide local excision for breast cancer are performed with the patient under general anaesthesia. The procedure is usually performed through an axillary incision, but it also can be performed using a periareolar incision or a combination of both types of incision. Under the guidance of an endoscope, carbon dioxide insufflation is used to create a working space and the breast tissue is dissected. Haemostasis is achieved by ligation and electrical coagulation. For an endoscopic mastectomy, the breast tissue, including the tumour, is separated from muscle and subcutaneous tissues, and removed. For an endoscopic wide excision, the part of the breast containing the tumour is removed, with an adequate margin of healthy breast tissue. Drains are inserted and the incisions closed.|
|2.2.2||As with other types of breast cancer surgery, adjuvant radiotherapy, chemotherapy or endocrine therapy may also be used|
|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/IP707overview.|
|2.3.1||A non-randomised controlled trial compared outcomes in 21 patients treated by endoscopic mastectomy and 25 patients treated by subcutaneous mastectomy without an endoscope, for early stage breast cancer (stages 1 or 2). The trial reported that all patients were alive at a median 19.2-month follow-up (range 5.8–35.2 months).|
|2.3.2||A case series of 131 patients with early breast cancer (and 19 patients with benign breast tumours) treated by endoscopic mastectomy (video assisted breast surgery) reported no locoregional recurrence at a mean follow-up of 28 months (maximum of 56 months).|
|2.3.3||A case series of 20 patients with breast cancer reported that 1 patient who had microcalcification in her remaining breast required total endoscopic mastectomy for multifocal carcinoma (at 6-month mammography).|
|2.3.4||In the non-randomised controlled trial of 46 patients with stage 1 or 2 breast cancer comparing endoscopic mastectomy with subcutaneous mastectomy without an endoscope, histological examination revealed positive resection margins requiring radiation therapy 4 weeks after surgery in 5% (1/21) and 8% (2/25) of patients, respectively. Two case series of 20 and 6 patients with breast cancer reported positive histological margins in 1 patient each. The first required endoscopic total mastectomy (10 days after the first operation) and the second was treated with ‘additional adjuvant radiotherapy'.|
|2.3.5||The non-randomised controlled trial of 46 patients reported that 86% (18/25) of patients treated by endoscopic mastectomy and 60% (15/25) of patients treated by subcutaneous mastectomy without an endoscope were considered to have an ‘excellent' cosmetic score at 6-month follow-up (that is, both the patient and surgeon were satisfied with the symmetry of the breast) (p = 0.15). In a case series including 82 patients treated by endoscopic mastectomy, cosmetic results were reported by patients using a scoring system called ABNSW (asymmetry, breast shape, nipple shape, skin condition and woundcare). Patients reported a mean score of 13.5 (on a scale of 0 [poor] to 15 [excellent]) (duration of follow-up not stated).|
|2.3.6||The Specialist Advisers considered key efficacy outcomes to include long term survival, adequacy of tumour clearance, tumour recurrence, cosmesis, patient satisfaction, postoperative pain control, time to return to work and length of hospital stay.|
|2.4.1||The case series including 82 patients with malignant tumours reported subcutaneous haemorrhage in 7 patients (9%) and haematoma in 2 patients (reoperation not required).|
|2.4.2||The case series of 82 patients reported second-degree burns in 4 patients (one burn occurred during skin flap formation near the nipple and three burns occurred during additional resection for positive surgical margins found on fast-frozen sections) The case series of 17 patients reported superficial burns on the skin flap of some patients, but did not provide any more details. The case series of 7 patients reported burning of the skin caused by the electrocautery in 2 patients (29%). In 1 patient, the burn required skin debridement.|
|2.4.3||The Specialist Advisers considered theoretical adverse events to include major neurovascular injury, pneumothorax, non-viable skin flaps and longer operating time than traditional open surgery.|
|2.5.1||The Committee noted that this procedure may also be used for benign breast lesions.|
Chairman, Interventional Procedures Advisory Committee
This page was last updated: 30 March 2010