There is limited evidence of short-term efficacy on endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of gastro-oesophageal reflux disease (GORD). This evidence also raises concerns about the procedure's safety. Therefore, this procedure should not be used without special arrangements for consent and for audit.
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 NICE's information for the public is recommended.
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).