Interventional Procedures Consultation Document - Endoscopic axillary lymph node retreival

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Endoscopic axillary lymph node retrieval for breast cancer

The National Institute for Health and Clinical Excellence is examining endoscopic axillary lymph node retrieval for breast cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about endoscopic axillary lymph node retrieval for breast 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 preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 26 July
Target date for publication of guidance: November 2005


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of endoscopic axillary lymph node retrieval for breast cancer does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

1.2

Clinicians wishing to undertake endoscopic axillary lymph node retrieval should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's Information for the public is recommended.
  • Audit and review clinical outcomes of all patients having endoscopic axillary lymph node retrieval for breast cancer.
1.3

This procedure should only be undertaken by surgeons skilled in endoscopic techniques.


2 The procedure
2.1 Indications
2.1.1 Axillary clearance is an integral part of surgery for breast cancer. Biopsy of lymph node tissue helps in the staging of breast cancer, providing prognostic information and identifying patients who will benefit from systemic therapy.
2.1.2

Traditionally, surgeons remove lymph nodes for staging through an incision in the axillary skin under direct vision. However, this procedure may have side effects including wound infection and lymphoedema. There are two surgical alternatives that are standard practice. The first involves clearance to level one, two or three of the axilla, taking up to 20 lymph nodes, which provides very accurate diagnostic information. The second requires sampling of a minimum of four lymph nodes, which causes less morbidity but provides only qualitative rather than quantitative information regarding the status of the axillary basin of lymph nodes. A new procedure is sentinel node mapping, which requires the use of imaging and specific training. Endoscopic techniques, sometimes combined with liposuction, have been developed as a less invasive approach to removing lymph nodes for diagnosis.

2.2 Outline of the procedure
2.2.1

In endoscopic axillary lymph node retrieval, very small incisions are made in the axillary skin and nodes are removed using an endoscope and special instruments. The patient is placed in a supine position under general anaesthesia. Liposuction is used to remove excess axillary fat. An endoscope is inserted through the incision used for liposuction, and trocars are introduced through two additional small incisions. Fibrous tracts and small lymph and blood vessels are coagulated and cut, and lymph nodes are freed and removed. Following a saline rinse of the surgical field, the incisions are sutured. Drains are not normally required.

2.3 Efficacy
2.3.1

Conversion to open surgery was reported in 8% (4/53) of operations in a historically controlled study. In a large case series the requirement for conversion was only 2% (2/100) of operations.

2.3.2 In one randomised controlled trial, the operative time for endoscopic axillary lymph node retrieval was found to be significantly longer than for open surgery (mean time 61 and 33 minutes, respectively).
2.3.3 One quasi-randomised study found good shoulder-arm mobility at 7 days postoperatively, with more than 90% mobility being achieved following either endoscopic axillary lymph node retrieval or open surgery. Only 18% (7/40) of patients who had endoscopic axillary lymph node retrieval reported pain on the first postoperative day, compared with 33% (13/40) of patients who had open surgery. One small randomised controlled trial found that all ten patients reported no pain at 3 days after endoscopic axillary lymph node retrieval.
2.3.4 Length of hospital stay following endoscopic axillary lymph node retrieval was found to vary widely from 2.5 days to 9 days, although one study reported that most of the later patients in the series were discharged within 24 hours.
2.3.5

Two case series reported no axillary recurrence among 100 and 103 patients followed up to 14 and 18 months respectively. For more details, refer to the sources of evidence (see Appendix).

 

2.4 Safety
2.4.1

Data on the safety of the procedure were not reported consistently across the studies. The incidence of seroma reported following endoscopic axillary lymph node retrieval varied widely from 90% (36/40) to 4% (4/100). Similarly, rates of haematoma formation ranged from 16% (16/100) in one case series to 1% (1/103) in a second case series.

2.4.2 Other reported adverse events following endoscopic axillary lymph node retrieval included lymphocoele in 25% (5/20) of patients and wound infection in 5% (2/40) of patients. For more details, refer to the sources of evidence (see Appendix).
2.4.3 The Specialist Advisors noted that theoretical adverse effects include bleeding, damage to nerves or the axillary artery, pneumothorax, lymphoedema and pain or sensory disturbance in the arm and shoulder.
2.5 Other comments
2.5.1 These recommendations refer to the use of laparoscopy rather than open surgery for the retrieval of selected axillary lymph nodes. It does not address clinical decisions about the number of lymph nodes that should be removed.
2.5.2 The Committee noted that this procedure is seldom carried out in the UK, and that sentinel node retrieval has become common practice.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2005

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • Interventional procedure overview of endoscopic axillary lymph node retrieval, March 2004

Available from: www.nice.org.uk/ip021overview

This page was last updated: 07 February 2011