Interventional procedure consultation document

Radiofrequency cold ablation for respiratory papillomatosis

Treating papillomas in the throat and airways using electrical energy

Respiratory papillomatosis is a condition in which non-cancerous wart-like growths called papillomas grow in the throat or airways. It affects both children and adults and can cause voice changes and shortness of breath. The condition is caused by the human papilloma virus and can keep coming back after treatment. This procedure aims to dissolve or shrink the papillomas using an electric current. The procedure uses a lower temperature than other treatments, with minimal heat damage to surrounding healthy tissue.

The National Institute for Health and Clinical Excellence (NICE) is examining radiofrequency cold ablation for respiratory papillomatosis 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 radiofrequency cold ablation for respiratory papillomatosis.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 24 July 2012

Target date for publication of guidance: 28 November 2012

1   Provisional recommendations

1.1   Current evidence on the safety and efficacy of radiofrequency cold ablation for respiratory papillomatosis is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake radiofrequency cold ablation for respiratory papillomatosis should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients and their carers/parents understand the uncertainty about the procedure’ssafety 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/guidance/IPGXXX/publicinfo). [[URL to be added at publication]]
• Audit and review clinical outcomes of all patients having radiofrequency cold ablation for respiratory papillomatosis (see section 3.1).

1.3   NICE encourages further research and data collection on radiofrequency cold ablation for respiratory papillomatosis. In particular, research and data collection should report treatment indication (whether for primary or secondary treatment of respiratory papillomatosis), outcomes related to timing and site of disease recurrence, the need for tracheostomy after the procedure, and longer-term survival. In addition, any effect of the procedure on voice quality should be documented.

1.4   Clinicians should enter details for all patients undergoing radiofrequency cold ablation for respiratory papillomatosis onto the International Registry for Airway Stenosis (http://www.airwayregistry.net/).

1.5   NICE may review the procedure on publication of further evidence.

2   The procedure

2.1   Indications and current treatments

2.1.1   Respiratory papillomatosis is a condition characterised by benign papillomatous (wart-like) growths in the respiratory tract, which can cause voice changes and airway obstruction. It can affect both children and adults. The condition tends to recur after treatment and is then known as recurrent respiratory papillomatosis.

2.1.2   Procedures to remove the papillomas surgically include the use of cold steel dissection, suction diathermy, cryotherapy, carbon dioxide (CO₂) or other lasers, or microdebridement. Any of these may be followed by systemic administration or direct injection of antiviral agents (for example, cidofovir) into the resection sites, with the aim of reducing the frequency of reoperative surgery. Tracheostomy may be needed if significant airway obstruction occurs.

2.2   Outline of the procedure

2.2.1   Radiofrequency cold ablation involves passing a radiofrequency bipolar electrical current through a medium of normal saline. This produces a plasma field of sodium ions that dissects the tissue by disrupting intercellular bonds, leading to tissue vaporisation and coagulation. Radiofrequency cold ablation heats tissue to only 60–65°C, which may produce less postoperative pain and damage to surrounding structures than conventional diathermy.

2.2.2   The procedure is usually done with the patient under general anaesthesia. Conventional microlaryngoscopy techniques allow introduction of a single-use radiofrequency probe into the lumen of the larynx and trachea.

2.2.3   Once the probe tip is in contact with the papillomata, it is activated to produce controlled tissue ablation of individual lesions, together with haemostasis and suction.

2.2.4   Steroids and antibiotics may be given after the procedure to reduce inflammation and the risk of infection.

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/992/overview

2.3   Efficacy

2.3.1   In a case series of 3 adult patients with recurrent papillomas of the nasopharynx, only 1 patient had a recurrent lesion at 4-month follow-up, which was successfully re-excised with endoscopic transnasal radiofrequency cold ablation. A case series reported ‘reduced disease recurrence’ (no further details provided) in 2 adult patients with juvenile-onset recurrent respiratory papillomatosis who had previously been treated repeatedly by CO₂ laser ablation; 1 was treated by radiofrequency cold ablation treatment alone and 1 by radiofrequency cold ablation together with CO₂ laser ablation. In a case report of 1 paediatric patient with a large de novo laryngeal papilloma treated by radiofrequency cold ablation alone, there was no sign of recurrence at 18-month follow-up.

2.3.2   In a case series of 6 adult patients with advanced laryngotracheal recurrent respiratory papillomatosis who had previously received at least 2 years of treatment by CO₂ laser ablation followed by at least 2 years of treatment by radiofrequency cold ablation, there was a significant increase (>50%) in the interval between treatments in 3 patients when radiofrequency cold ablation was introduced (p=0.03) and a modest increase (<25%) in the interval between treatments in the other 3 patients (p value not reported).

2.3.3   In another case series of 2 adult patients with extensive and recurrent laryngeal papillomas, 1 patient who presented with severe hoarseness and exertional dyspnoea was found to have a good voice with no exertional dyspnoea at 2-month follow-up (no formal assessment of voice quality reported; no results were presented for the other patient). In the case report of 1 paediatric patient, a dramatic improvement in voice quality was observed (no formal assessment of voice quality reported).

2.3.4   The Specialist Advisers listed key efficacy outcomes as reduction in the number or frequency of microlaryngoscopy procedures needed to maintain a safe airway, and achievement of good voice quality.

2.4   Safety

2.4.1   Minor scarring around the ablated tissues was reported in all patients in a case series of 18 patients (method of assessment of scarring not described).

2.4.2   Respiratory papillomas appeared at a new location 4 months after radiofrequency cold ablation in 1 patient in the case series of 18 patients. The procedure was repeated with no further recurrence at 2-month follow-up.

2.4.3   The Specialist Advisers listed theoretical adverse events as laryngeal or airway scarring (with airway stenosis and dysphonia as possible consequences of scarring to the larynx), bleeding and inadequate reduction in the number and size of papillomas, leading to inability to maintain a safe airway.

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.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 2012

_{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.}