Gastro-oesophageal reflux disease is caused by backward movement (reflux) of the stomach contents into the oesophagus. This occurs when the ring of muscles at the lower end of the oesophagus fails to work properly. This procedure aims to stop the reflux by implanting material to bulk out the sides of the oesophagus.

The National Institute for Health and Clinical Excellence is examining endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of gastro-oesophageal reflux disease 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 endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of gastro-oesophageal reflux disease.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 March 2007
Target date for publication of guidance: June 2007

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

Clinicians wishing to undertake endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of GORD should take the following actions.

? Inform the clinical governance leads in their Trusts.

? Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

? Audit and review clinical outcomes of all patients having endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of GORD (see section 3.1).

Any adverse events resulting from the procedure should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA).

GORD is caused by failure of the sphincter mechanism at the lower end of the oesophagus. It is commonly associated with hiatus hernia.

Mild symptoms of GORD can be managed with lifestyle modification and pharmacological therapy, which are effective in most patients. However, anti-reflux surgery may be required for those with refractory symptoms or persistent oesophagitis.

In one case series (n = 69), GORD/heartburn-related quality-of-life (GORD-HRQL) scores improved significantly, from 24 at baseline (n = 64) to 5 at 6 months (n = 53; p < 0.05).="" similarly,="" regurgitation="" scores="" improved,="" from="" 16="" at="" baseline="" (n="55)" to="" 2="" at="" 6="" months="" (n="49;" p="">< 0.05).="" physical="" aspects="" of="" quality-of-life="" (as="" measured="" by="" the="" sf-36="" health="" survey)="" improved="" significantly="" over="" 6="" months="" (from="" 43="" at="" baseline="" [n="60]" to="" 52="" at="" 6="" months="" [n="57];" p="">< 0.05),="" but="" the="" mental="" component="" of="" quality-of-life="" did="" not="" change="" significantly="" (from="" 49="" at="" baseline="" [n="60]" to="" 50="" at="" 6="" months="" [n="">

In the case series of 69 patients oesophagitis was reported to be present at baseline in 58% of patients (39/67) and at 6 months in 32% (17/53).

The Specialist Advisers expressed uncertainty as to whether the procedure has a long-lasting effect. They commented that few patients have shown a sustained reduction in objective measures of GORD, such as oesophageal acid exposure, after the procedure.

The case series of 69 patients reported safety outcomes. One patient's pharynx was perforated during overtube insertion, requiring a week of inpatient care but surgical intervention was not required. In this case series the most common complication reported was erosion of the prosthesis into the oesophagus which occurred in 22% (15/67) of patients by 6 months. For more details, refer to the sources of evidence (see appendix).

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 augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of gastro-oesophageal reflux disease', January 2007.