The National Institute for Clinical Excellence is examining endoscopic stapling of pharyngeal pouch 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 endoscopic stapling of pharyngeal pouch.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation 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: 22 July 2003

Target date for publication of guidance: 24 December 2003

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 endoscopic stapling of pharyngeal pouch appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

The Interventional Procedures Advisory Committee also noted that training and post-operative care are of great importance. The 1996/97 Annual Report of the National Confidential Enquiry into Peri-operative Deaths (www.ncepod.org.uk/reports.htm) recommended that sub-specialisation within otorhinolaryngology departments should occur for this procedure.

Pharyngeal pouch, which is also known as Zenker's diverticulum, occurs when a piece of the pharyneal lining herniates through the muscles of the pharyngeal wall. It occurs mainly in older people, with an estimated overall incidence of about 1 per 100,000 persons per year.

A pharyngeal pouch may cause difficulty in swallowing or cough, and sometimes causes respiratory problems because of aspiration of the pouch contents into the lungs.

The traditional treatment for pharyngeal pouches is open surgery to the neck. Endoscopic techniques are less invasive than open surgery. The standard endoscopic technique, known as Dohlman's procedure, involves diathermy or lasers to divide the wall between the pouch and the oesophagus. Endoscopic stapling of pharyngeal pouch is an alternative to the standard endoscopic technique.

Endoscopic stapling of pharyngeal pouch involves stapling of the opening of the pharyngeal pouch using a specially designed endoscope, while the patient is under general anaesthetic.

The evidence suggested that endoscopic stapling allows a more rapid recovery, and requires a shorter stay in hospital (2 days) than open surgery. However the effectiveness of the procedure compared with other procedures remains uncertain. For more details refer to the overview (see below).

Specialist Advisors considered endoscopic stapling to be an established procedure, now widely practiced in specialist centres by specifically trained otorhinolaryngologists. They considered it effective in terms of reducing operating time, and the duration of hospital stay.

The Specialist Advisors noted that there was a relatively high recurrence rate but that the procedure could be repeated.

Few complications were reported in the studies reviewed. Mild bleeding, perforation of the pharynx and a need for nasogastric feeding were reported, but this was uncommon. For more details refer to the overview (see below).

Specialist Advisors concurred that perforation and leakage from the pharynx could occur, but were no more common with endoscopic stapling than with alternative procedures.

There is a lack of good long-term data. The Interventional Procedures Advisory Committee therefore recommended that an audit, including data on recurrence, should be carried out.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Endoscopic Stapling of Pharyngeal Pouch, November 2002