The Interventional Procedures Advisory Committee (IPAC) has considered this procedure and NICE has issued a consultation document about its safety and efficacy. Consultation has now ended. IPAC will consider the consultation comments and produce a Final Interventional Procedures Document, which will be considered by NICE before guidance is issued to the NHS in England, Wales, Scotland and Northern Ireland.
The consultation period for this procedure closed on the 23 April 2014
This guidance updates and replaces NICE interventional procedures guidance 82 and 244.
This guidance has been partially updated by Endoscopic radiofrequency ablation for Barrett’s oesophagus with low-grade dysplasia or no dysplasia (NICE interventional procedures guidance 496).
Barrett’s oesophagus is a premalignant condition characterised by the abnormal partial replacement of the squamous epithelium (lining) of the oesophagus by a type of columnar epithelium found elsewhere in the gastrointestinal tract. Typically these changes occur in segments of the lower oesophagus, at varying lengths.
The condition is thought to be asymptomatic, although patients may have history of heartburn, as there is a strong association of Barrett’s oesophagus with gastro-oesophageal reflux disease (GORD).
The epithelium in patients with Barrett’s oesophagus may be of normal microscopic appearance (metaplasia) or may have abnormal cellular architecture (either low- or high-grade dysplasia [LGD and HGD, respectively]). In some patients, Barrett’s oesophagus may progress through a series of stages (from metaplasia to LGD and then HGD) to oesophageal adenocarcinoma – a cancer with a poor prognosis.
The risk of progression to oesophageal adenocarcinoma is difficult to predict accurately. Overall, the risk of cancer progression is highest for patients with HGD, lower for patients with LGD, and even lower for patients with metaplastic-only Barrett’s oesophagus. However, ‘regression’ from HGD to LGD as well as from LGD to metaplasia is also known to occur in some patients. There is uncertainty about the rate of progression (for example, from LGD to HGD), as well as the rate of ‘regression’ (for example, from HGD to LGD). In addition, accurate classification of Barrett’s oesophagus into these distinct histopathological types requires multiple biopsy sampling and specialist histopathological expertise. There is the possibility of diagnostic misclassification due to biopsy sampling error and biopsy interpretation.
The management of patients with Barrett’s oesophagus is determined by their dysplasia status. For patients with metaplastic (non-dysplastic) Barrett’s oesophagus or LGD, periodic endoscopic surveillance and re-biopsy is traditionally recommended, with the aim of detecting potential progression to HGD or cancer early.
In contrast, for patients with HGD, management options include either very frequent (3-monthly) endoscopic surveillance and re-biopsy or oesophagectomy. (The rationale for oesophagectomy is that some patients with HGD may also have intra-mucosal adenocarcinoma lesions in parts of their oesophagus which were missed by the biopsy.)
For HGD patients, during the last 10 years, a series of non-surgical, endoscopic treatments have also been developed. These include endoscopic mucosal resection and ablative modalities, including photodynamic therapy (PDT), argon plasma coagulation (APC), laser ablation, cryotherapy, multipolar electrocoagulation and radiofrequency ablation (RFA). The aim of ablative treatments is to destroy the Barrett’s epithelium, leaving a surface which is subsequently re-epithelialised with squamous epithelium.
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.