Circumferential epithelial radiofrequency ablation for Barrett's oesophagus (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Circumferential epithelial radiofrequency ablation for Barrett's oesophagus

Barrett's oesophagus is a condition in which the lining of the gullet (oesophagus) becomes damaged by regular reflux of stomach contents over many years; this can be a precursor to the development of cancer. In circumferential radiofrequency ablation, a thin layer of the gullet's lining is burned using a device inserted with the help of a camera, with the intention of destroying damaged cells and therefore possibly avoiding progression to cancer.


The National Institute for Health and Clinical Excellence is examining circumferential epithelial radiofrequency ablation for Barrett's oesophagus 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 circumferential epithelial radiofrequency ablation for Barrett's oesophagus.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 21 August 2007
Target date for publication of guidance: December 2007


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


1 Provisional recommendations
 
1.1 Evidence on the safety and efficacy of circumferential epithelial radiofrequency ablation for Barrett's oesophagus is currently inadequate. The evidence is limited in quantity and duration of follow-up, and fails to justify the grade of Barrett's being treated. Therefore this procedure should only be used in the context of research.
1.2 Further research should clearly specify the grade of Barrett's oesophagus being treated and should include arrangements for long-term follow-up (for example 5 years).
 
 
2 The procedure
 
2.1 Indications
 
2.1.1 Barrett's oesophagus is a condition characterised by an abnormal lining (epithelium) of the oesophagus. It is associated with gastro oesophageal reflux disease (GORD). In some people Barrett's oesophagus may progress through a series of precancerous stages (dysplasia) to cancer. High-grade dysplasia is the histological stage preceding cancer, but it is not possible to predict how soon such lesions will progress to cancer.
2.1.2 Oesophagectomy is the most radical treatment option for high-grade dysplasia in Barrett?s disease. Removal of the whole oesophagus takes away the risk of progression to cancer, but oesophagectomy is a major operation with potential high morbidity and mortality. Furthermore, some patients are unfit for surgery or reluctant to undergo this operation for a premalignant condition.
2.1.3 Less invasive treatments for high-grade dysplasia aim to remove the specialised columnar epithelium associated with Barrett's and promote the regeneration of normal squamous epithelium. Treatments include laser ablation, endoscopic mucosal resection, and photodynamic therapy. Follow-up by endoscopic surveillance is usually required to detect development of further dysplastic changes and/or cancer.
 
 
2.2 Outline of the procedure
 
2.2.1 The aim of circumferential radiofrequency (RF) ablation is to destroy a thin layer of oesophageal epithelium around the lumen of the oesophagus for a length of a few centimetres.
2.2.2 The procedure is carried out under conscious sedation. Under endoscopic visualisation, a balloon-mounted coil measuring a few centimetres in length and attached to a probe is inserted into oesophageal lumen and advanced to the level of the target area. The coil delivers a controlled emission of RF energy for a few seconds, which ablates a thin layer of epithelial tissue. Repeat treatments may be necessary if follow-up endoscopy shows residual Barrett's oesophagus.
 
 
2.3 Efficacy
 
2.3.1 A case series of 102 patients reported on dosimetry in 32 patients and effectiveness in 70 patients. Intention-to-treat analysis demonstrated a complete response to circumferential RF ablation (defined as 100% of biopsy samples reported negative for Barrett's oesophagus) in 59% (19/31) and 69% (48/69) of patients respectively in the dosimetry and effectiveness phases of the study (at 12 months' follow-up). A second case series of 7 patients treated after fundoplication for GORD reported that 6 patients were Barrett's oesophagus-free on endoscopic examination at 3 months' follow-up.
 
2.3.2 In the same case series of 7 patients, gastro-oesophageal health related quality of life (QOL) scores improved from a median of 2 points at baseline to 1 point at 1-2 weeks' follow-up (not statistically significant ; see sources of evidence for details of QOL scale). For more details, refer to the sources of evidence (see appendix).
2.3.3 Two Specialist Advisers stated that the benefit of the procedure is complete ablation of Barrett's oesophagus without the creation of strictures. Three Specialist Advisers noted the lack of long-term data. Key efficacy outcomes were considered to be complete ablation of Barrett's with no stricture, visual and histological reversal of metaplasia, reduction in the presence of dysplasia and reduced incidence of carcinoma.
 
2.4 Safety
 
2.4.1 In the first case series of 102 patients, all reported that adverse events were transient and resolved completely. The 106 procedures undertaken in the effectiveness phase of this study (including 36 repeat treatments) included nausea in 8% of patients (8/106) and fever in 2% (2/106). There was one occurrence each (1% each) of mild bleeding, mucosal scarring, linear mucosal injury, airway obstruction and hypotension (the latter two complications were thought to relate to the sedation used for the procedure). All these complications were transient and resolved completely.
2.4.2 In the same case series there were no reports of strictures or buried glands in any of the 3007 biopsies taken during the study.
2.4.3 The second case series of 7 patients reported that there were no procedure-related complications and that there were no new or recurrent GORD-like symptoms at 3 months? follow-up. For more details, refer to the sources of evidence (see appendix).
2.4.4 The Specialist Advisers identified stricture, perforation, pain, haemorrhage, and buried malignancy beneath neo-squamous epithelium as adverse events.
3 Further information
3.1 The Institute has issued Interventional Procedures guidance on photodynamic therapy for high-grade dysplasia in Barrett's oesophagus (ipg82) and thoracoscopically assisted oesophagectomy (ipg189).
   

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2007

Appendix: Sources of evidence
 

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • 'Interventional procedure overview of circumferential epithelial radiofrequency ablation for Barrett's oesophagus, April 2007'

Available from: www.nice.org.uk/ip397overview.

This page was last updated: 25 May 2010