The National Institute for Clinical Excellence is examining endoscopic injection of a bio-compatible polymer for gastro-oesophageal reflux disease 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 injection of a bio-compatible polymer for gastro-oesophageal reflux disease.

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 Procedure 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: 27 January 2004

Target date for publication of guidance: April 2004

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 injection of bio-compatible polymer for gastro-oesophageal reflux disease does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake endoscopic injection of bio-compatible polymer for gastro-oesophageal reflux disease should:

• inform the clinical governance leads in their Trusts.
• ensure that patients 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.
• audit and review clinical outcomes of all patients having endoscopic injection of bio-compatible polymer for gastro-oesophageal reflux disease. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.

Gastro-oesophageal reflux disease (GORD) is a common condition that can have a significant impact on the quality of life of an individual. It is caused by failure of the sphincter mechanism at the lower end of the oesophagus. Symptoms of GORD can be broadly grouped into those directly related to reflux episodes such as heartburn, regurgitation and waterbrash; and those symptoms caused by complications of reflux disease, including dysphagia and respiratory symptoms.

Drug therapy, combined with lifestyle modifications, is the standard treatment for patients with mild symptomatic GORD. Patients with more severe symptoms or oesophagitis may be treated with more intensive drug therapy and anti-reflux surgery may be needed.

The patient is sedated and given an injection of antibiotics. A needle catheter is then introduced through an endoscope into the gastro-oesophageal junction. This catheter is filled with a bio-compatible polymer and solvent and is used to inject or implant the polymer into the gastro-oesophageal junction. The injection is made along the muscle layer or deep submucosal layer of the cardia. Multiple injection/implants (often four) are performed in a circumferential manner around the oesophagus under fluoroscopic and endoscopic control.

Evidence of efficacy was based primarily on one uncontrolled study of 85 patients. This study reported that, at 12 months, 65 patients (77%) had reduced their medication dose of proton pump inhibitors by 50% or more. Both heartburn and regurgitation symptom scores had improved by 12 months; improvement in quality of life was also reported at final follow-up. However, at 12 months a significant number of patients still had persistent acid reflux and low-grade inflammation in the lower oesophagus.

The Specialist Advisors considered that this was a procedure at an early stage of development and that its efficacy was unknown.

Transient mild-to-moderate chest pain was the most commonly reported adverse event occurring after implantation; the incidence in the studies ranged from 53% (8/15) to 92% (78/85). Other complications included dysphagia, fever and nausea.

One Specialist Advisor noted that stricture at the gastro-oesophageal junction was a potential complication.

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

• Interventional Procedure Overview of endoscopic injection of bio-compatible polymer for gastro-oesophageal reflux disease, August 2003

Available from: www.nice.org.uk/ip226overview