This procedure involves the use of a flexible tube (endoscope) to enter and visualise a salivary gland, to remove stones which can block the gland.

The National Institute for Health and Clinical Excellence is examining therapeutic sialendoscopy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 therapeutic sialendoscopy.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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: 27 February 2007
Target date for publication of guidance: May 2007

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

Current evidence on the safety and efficacy of therapeutic sialendoscopy appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Therapeutic sialendoscopy is used in the treatment of suspected salivary gland obstruction. Obstruction of the ducts is most commonly caused by sialolithiasis (stones) and, more rarely, by tumours.

Symptoms of salivary gland obstruction are varied and include swelling of the face or neck, swelling in front of the ear, pain in the face or mouth, decreased ability to open the mouth and a dry mouth.

The evidence of efficacy was based on five case series. Across these studies therapeutic sialendoscopy relieved duct obstruction in between 82% (90/110) and 87% (47/54) of cases.

In a study of 72 patients, 8% (6/72) had continuing symptoms or other clinical problems which did not improve after the procedure and required removal of the gland (sialadenectomy). In another study of 129 patients, 110 of whom underwent therapeutic sialendoscopy, the treatment was considered a failure in 18% (20/110) of patients, five of whom required gland removal.

The Specialist Advisers did not consider there to be any uncertainties about this procedure. One Adviser noted that high success rates are reported in the published literature.

Few complications were reported in the five case series reviewed. Temporary swelling of the gland was common. In one study of 129 patients, ductal wall perforation occurred in 11 patients (9%), with two of these patients requiring hospitalisation and one patient undergoing gland resection. Three other studies reported cases of salivary gland perforation with an incidence of between < 1%="" and="" 5%="" (3/55="" 1/103,="" 1/236).="" one="" patient="" (1/236)="" developed="" lingual="" nerve="" paraesthesia="" caused="" by="" the="" perforation.="" ductal="" strictures="" were="" also="" reported="" in="" seven="" patients="" (3%)="" in="" a="" case="" series="" of="" 236="" patients.="" five="" patients="" underwent="" successful="" dilatation="" but="" two="" required="" open="" surgery.="" other="" complications="" included="" wire="" retrieval="" basket="" blockages="" and="" infection.="" for="" more="" details,="" refer="" to="" the="" sources="" of="" evidence="" (see="">

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

• 'Interventional procedure overview of therapeutic sialendoscopy', November 2006 .