The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Endoscopic injection of bulking agents for gastro-oesophageal reflux disease.
As part of the NICE's work programme, the current guidance was considered for review but did not meet the review criteria as set out in the IP process guide. The guidance below therefore remains current.
June 2016 – Please note that the device linked to this guidance has been withdrawn by the manufacturer. Further information can be found at gov.uk’s alerts and recalls for drugs and medical devices. NICE may review this guidance should additional information be made available.
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.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.