Interventional procedure consultation document - cyanoacrylate instillation for occlusion of parotid sinuses

Untitled Document

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Cyanoacrylate instillation for occlusion of parotid sinuses

The National Institute for Clinical Excellence is examining the cyanoacrylate instillation for occlusion of parotid sinuses and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 cyanoacrylate instillation for occlusion of parotid sinuses.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

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 the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
  • The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

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

Closing date for comments: 25 November 2003

Target date for publication of guidance: May 2004


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 cyanoacrylate instillation for occlusion of parotid sinuses is not adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake cyanoacrylate instillation for occlusion of parotid sinuses should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.


2 The procedure
2.1 Indications
2.1.1

Superficial parotid gland surgery may be complicated in about 10-15% of patients by the development of an abnormal tract (sinus) between the remnants of the parotid gland and the outer surface of the cheek. The sinus may have unwanted cosmetic effects, and may cause chronic leakage of saliva with excoriation of the cheek.

2.1.2

Alternative treatments for parotid sinus include watchful waiting, bandaging, radiotherapy, local denervation of the gland or excision of the deep lobe of the parotid gland.

2.2 Outline of the procedure
2.2.1

A solution of lipiodol and cyanoacrylate is injected via the sinus into the parotid gland, sealing the sinus. If the procedure is unsuccessful and symptoms recur the procedure can be repeated. For more details, refer to the Overview (see Appendix).

2.3 Efficacy
2.3.1

The evidence was limited to one case report. Although this demonstrated the feasibility of the technique, the report was uncontrolled and did not provide any further information about efficacy and safety. For more details, refer to the Overview (see Appendix).

2.3.2

No specialist advice was provided for this procedure. The Advisors who were approached were unaware of the technique.

2.4 Safety
2.4.1

See point 2.3.1

2.4.2

No specialist advice was provided for this procedure. The Advisors who were approached were unaware of the technique.

2.5 Other comments
2.5.1

The procedure appears to have been carried out once, on one patient, by one clinician. Anyone considering its use may wish to contact that clinician, Mr AJ Marcus of the Edgware Hospital.


Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
November 2003

Appendix: Sources of evidence

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

  • Interventional Procedure Overview of Cyanoacrylate instillation for occlusion of parotid sinuses, October 2002

Available from: www.nice.org.uk/ip068overview

This page was last updated: 07 February 2011