Interventional procedure consultation document

Endoscopic radical inguinal lymphadenectomy

Treating cancer using keyhole removal of lymph nodes in the groin

Inguinal lymph nodes are removed in the routine management of genital or anal cancer, and melanoma of the leg through an incision in the groin.  This ‘open’ procedure may cause discomfort, scarring and other complications. This alternative procedure uses an endoscopic device and small incisions with the aim of reducing the complications associated with the ‘open’ procedure. Robotic control may also be used.

The National Institute for Health and Clinical Excellence (NICE) is examining endoscopic radical inguinal lymphadenectomy 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 radical inguinal lymphadenectomy.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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

Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that 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 March

Target date for publication of guidance: June 2011

1   Provisional recommendations

1.1  Current evidence on the safety and efficacy of endoscopic radical inguinal lymphadenectomy is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2  Clinicians wishing to undertake endoscopic radical inguinal lymphadenectomy 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 and 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 endoscopic radical inguinal lymphadenectomy (see section 3.1).

1.3  This procedure should be carried out only in centres that treat cancer patients requiring radical inguinal lymphadenectomy as part of their management, and by surgeons with training and experience in this type of endoscopic surgery.

1.4  Publications on the use of this procedure should clearly describe case selection, and should report rates of local recurrence and survival, as well as adverse events. NICE may review this procedure on publication of further evidence.

2   The procedure

2.1  Indications and current treatments

2.1.1  Patients with penile, vulval or anal cancer, or melanoma of the leg, may require radical inguinal lymphadenectomy as part of their management.

2.1.2  The standard method for radical inguinal lymphadenectomy is an open operation through an incision in the groin.

2.2   Outline of the procedure

2.2.1  The endoscopic approach has theoretical advantages of reduced postoperative pain, morbidity and recovery time compared with the open procedure.

2.2.2  Endoscopic radical inguinal lymphadenectomy is carried out with the patient under general anaesthesia. Ultrasound guidance may be used. Three or four small incisions are made in the area of the femoral triangle for insertion of ports and the working space is insufflated with CO₂. The lymph nodes are dissected endoscopically. Resected nodes are placed in an impermeable sac and removed through one of the port sites. Resection of the saphenous vein may also be required. A suction drain is normally inserted at the end of the 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 www.nice.org.uk/guidance/IP/879/overview

2.3   Efficacy

2.3.1  A non-randomised study of 15 patients (30 limbs) treated by endoscopic (20 limbs) or open (10 limbs) radical inguinal lymphadenectomy reported that the mean number of lymph nodes removed was 10.75 and 9.7 respectively (p = 0.3).

2.3.2  A case series of 5 patients reported recurrence in 2 patients. One patient had recurrence with multiple visceral metastases after the procedure. The other patient had recurrence in a lymph node outside the inguinal area, which was subsequently resected (follow-up not stated).

2.3.3  In the non-randomised study of 15 patients treated by endoscopic or open radical inguinal lymphadenectomy, mean length of hospital stay in patients who had the endoscopic procedure in one lower limb and the open procedure in the other (n = 10) was 6.4 days compared with 24 hours for patients who had bilateral endoscopic procedures (n = 5) (p < 0.001).  Mean times to return to usual activities were 21 days and 14 days respectively (p = 0.032).

2.3.4  The non-randomised study of 15 patients reported that wound drains remained in place for a shorter time after the endoscopic procedure compared with the open procedure  (4.9 days vs 6.4 days, p = 0.008).

2.3.5  The Specialist Advisers listed key efficacy outcomes as conversion to open procedure, length of hospital stay and time to full recovery, adequate clearance of lymph nodes and recurrence of cancer.

2.4   Safety

2.4.1  The non-randomised study of 15 patients reported lymphatic complications in both groups (10% [2/20] vs 20% [2/10], p = 0.58) during a 32-month follow-up. In the endoscopic group, complications related to 1 patient with lymphorrhoea and 1 patient with unilateral limited lymphocele (required 3 evacuation punctures).  In the open group, they related to 1 patient with chronic lymphoedema and 1 patient with lymphocele (spontaneously resolved by 2 months). A case series of 8 patients reported 3 patients with lymphoceles.

2.4.2  The non-randomised study of 15 patients reported a higher proportion of skin-related complications in the open group (5% [1/20] vs 50% [5/10] p = 0.009). In the endoscopic group, there was 1 patient with a small area of skin necrosis. In the open group, there were 3 patients with a small area of skin necrosis (no skin graft needed).

2.4.3  Among the 5 patients with skin-related complications in the non-randomised study of 15 patients, 1 had wound infection and 1 had cellulitis. A case series of 5 patients reported cellulitis in 2 patients; 1 of these patients had a severe infection at the site of prior sentinel node biopsy (follow-up not stated).

2.4.4  The Specialist Advisers considered theoretical adverse events to include damage to femoral vessel or femoral nerve, port site metastasis, gas embolus, lymph leak, lymphoedema, lymphocele and seroma.

2.5   Other comments

2.5.1  The Committee noted the potential of endoscopic radical inguinal lymphadenectomy to reduce the morbidity rate associated with the open procedure. They also noted that endoscopic radical inguinal lymphadenectomy is an uncommon procedure and considered that acquisition of comparative data may therefore be difficult. 

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 an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

February 2011

_{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.}