Epithelial radiofrequency ablation for Barrett's oesophagus

# Guidance
This guidance replaces the previous guidance on Circumferential epithelial radiofrequency ablation for Barrett's oesophagus (Interventional Procedures Guidance no. 244 November 2008). This guidance has been partially updated by Endoscopic radiofrequency ablation for Barrett's oesophagus with low-grade dysplasia or no dysplasia (NICE interventional procedure guidance 496).
Current evidence on the efficacy of epithelial radiofrequency ablation (RFA) in patients with Barrett's oesophagus with high-grade dysplasia (HGD) is adequate, provided that patients are followed up in the long term. There are no major safety concerns. Therefore this procedure may be used in patients with Barrett's oesophagus with HGD provided that normal arrangements are in place for clinical governance, consent and audit.
This recommendation has been updated and replaced by NICE interventional procedure guidance 496 (Endoscopic radiofrequency ablation for Barrett's oesophagus with low-grade dysplasia or no dysplasia).
This recommendation has been updated and replaced by NICE interventional procedure guidance 496 (Endoscopic radiofrequency ablation for Barrett's oesophagus with low-grade dysplasia or no dysplasia).
Patient selection for epithelial RFA for Barrett's oesophagus should be done by a multidisciplinary team experienced in the management of Barrett's oesophagus.
Epithelial RFA for Barrett's oesophagus should only be carried out by endoscopists with specific training in this procedure.
NICE encourages further research into epithelial RFA for Barrett's oesophagus. This should address the balance of risks and benefits of the procedure in patients with Barrett's oesophagus and either LGD or no dysplasia, and long-term outcomes in patients with Barrett's oesophagus of any histological type. This recommendation has been partially updated by NICE interventional procedure guidance 496 (Endoscopic radiofrequency ablation for Barrett's oesophagus with low-grade dysplasia or no dysplasia).# The procedure

# Indications and current treatments
Barrett's oesophagus is a condition characterised by abnormal epithelium of the oesophagus. In some patients, Barrett's oesophagus may progress, through metaplasia and dysplasia, to oesophageal adenocarcinoma. Cancer risk is higher for patients with HGD (some of whom may already have developed early-stage cancer) and lower for patients with LGD or no dysplasia.
Patients with HGD are usually offered oesophagectomy, or frequent endoscopic surveillance and re-biopsy (with the aim of detecting neoplastic changes early). Endoscopic treatments that aim to remove or ablate abnormal epithelium have also been developed, including endoscopic mucosal resection and photodynamic therapy.
Patients with LGD or no dysplasia are usually offered regular endoscopic surveillance and re-biopsy (with the aim of detecting potential progression to HGD or cancer).

# Outline of the procedure
The aim of RFA is to destroy the Barrett's epithelium in order to allow re-epithelialisation with squamous epithelium.
The procedure is carried out with the patient under conscious sedation, usually in an outpatient setting. Using endoscopic visualisation, an appropriately sized RFA probe is inserted into the oesophagus and advanced to the target area. Controlled pulses of RF energy are delivered to thermally ablate a thin epithelial layer in the affected areas. RFA is sometimes used after previous endoscopic mucosal resection.
If follow-up endoscopy and re-biopsy show residual Barrett's changes, repeat treatment sessions may be necessary.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

# Efficacy
A randomised controlled trial (RCT) of 127 patients (63 with HGD and 64 with LGD) treated by RFA or a sham procedure reported complete eradication of Barrett's oesophagus in 77% (65/84) and 2% (1/43) of patients respectively at 12-month follow-up (p < 0.001).
In the same RCT, among patients with HGD, fewer RFA-treated patients progressed to cancer at 12-month follow-up (2% ) compared with those in the sham group (19% ) (p = 0.04).
A register of 142 patients with HGD reported efficacy data on 92 patients with at least 1 follow-up endoscopy. At a median 1-year follow-up, HGD resolution had occurred in 90% (83/92) of patients; 80% (74/92) had no dysplasia (HGD or LGD) and 54% (50/92) had no Barrett's at all.
The Specialist Advisers listed key efficacy outcomes as eradication of metaplasia and dysplasia, relapse rate and reduction in development of cancer.

# Safety
Oesophageal stricture was reported in 6% (5/84) of patients treated by RFA in the RCT of 127 patients (successfully treated by endoscopic dilatation) and 8 patients (denominator not stated) from a register of 106 patients treated by RFA (timing of events and management not stated).
Buried glandular mucosa detected on surveillance biopsy was reported in 15% (4/27) of patients 612 weeks after RFA (precise timing of detection not stated) in a case series of 27 patients. All were treated with additional RFA. One buried glandular mucosa was reported in neosquamous epithelium among 1475 biopsies (less than 1%) in a case series of 44 patients (subsequent treatment not described).
In the RCT of 127 patients, 1 patient developed new-onset chest pain and 1 patient developed chest discomfort and nausea. Both patients required overnight admission to hospital.
The Specialist Advisers listed anecdotal adverse events as dysphagia, minor bleeding, oesophageal perforation and pain (such as retrosternal pain).# Further information
This guidance requires that clinicians undertaking the procedure in patients with LGD or no dysphagia make special arrangements for audit. NICE has identified relevant audit criteria and developed an audit tool (which is for use at local discretion).
For related NICE guidance see our website.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# Other NICE recommendations on epithelial radiofrequency ablation
Further recommendations have been made as part of the clinical guideline on Barrett's oesophagus  ablative therapy published in August 2010, as follows:
Consider using radiofrequency ablation alone or photodynamic therapy alone for flat high-grade dysplasia, taking into account the evidence of their long-term efficacy, cost and complication rates.
Clinical and cost-effectiveness evidence was reviewed in the development of this guideline which has led to this more specific recommendation. More information is available.
The IP guidance on epithelial radiofrequency ablation for Barrett's oesophagus remains current, and should be read in conjunction with the clinical guideline.# About this guidance
NICE interventional procedures guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHS Scotland.
This guidance was developed using the NICE interventional procedures guidance process.
It updates and replaces NICE interventional procedure guidance 244.
We have produced a summary of this guidance for patients and carers. Tools to help you put the guidance into practice and information about the evidence it is based on are also available.
Changes since publication
July 2014: This guidance has been partially updated by Endoscopic radiofrequency ablation for Barrett's oesophagus with low-grade dysplasia or no dysplasia (NICE interventional procedure guidance 496).
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2010. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
Contact NICE
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