Interventional procedure consultation document

Endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus

Squamous dysplasia is abnormal cells on the inside lining of the oesophagus (gullet). It may lead to cancer. In endoscopic radiofrequency ablation, the abnormal cells are destroyed by a coil-like device inserted through the mouth and into the oesophagus.

 

The National Institute for Health and Care Excellence (NICE) is examining endoscopic radiofrequency ablation for squamous dysplasia of the oesophagusand will publish guidance on its safety and efficacy to the NHS. NICE’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 endoscopic radiofrequency ablation for squamous dysplasia of the 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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 18 April 2014

Target date for publication of guidance: July 2014

 

 

 

 

1                      Provisional recommendations

1.1                  Current evidence on the efficacy of endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus is inadequate in quality and quantity. With regard to safety, there are well‑recognised complications, particularly oesophageal strictures. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2                  Clinicians wishing to undertake endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus should take the following actions.

·      Inform the clinical governance leads in their NHS trusts.

·      Ensure that patients understand the uncertainties about the procedure’s safety and efficacy, inform them about alternative treatment options and provide them with clear written information. In addition, the use of NICE’s information for the public [[URL to be added at publication]] is recommended.

1.3                  Patient selection for endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus should be done by a multidisciplinary team experienced in the management of oesophageal dysplasia.

1.4                  Endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus should only be done by endoscopists with specific training in this procedure.

1.5                  NICE encourages further research into endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus, including observational data collection. Studies should clearly define patient selection. Outcomes should include completeness of ablation, resolution of squamous dysplasia, progression to cancer and quality of life. All complications should be reported, particularly development of oesophageal strictures.

1.6                  Clinicians should enter details about all patients undergoing endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus onto the UK National HALO patient register, and review clinical outcomes locally.

 

 

 

 

2                      Indications and current treatments

2.1                  Squamous dysplasia of the oesophagus consists of flat premalignant epithelial lesions that may progress to squamous cell carcinoma. The World Health Organization’s (WHO) histologic classification of gastrointestinal tumours refers to squamous dysplasia as squamous intra-epithelial neoplasia (defined as non-invasive cytological or architectural alterations that may lead to development of invasive cancer) and categorises it as either low- or high-grade. Low-grade squamous dysplasia is associated with a low risk of progression to invasive squamous cell carcinoma, whereas high-grade intra-epithelial neoplasia carries a higher risk of progression.

2.2                  Squamous cancer of the oesophagus can be treated by surgery (oesophagectomy) or chemoradiotherapy or a combination of these methods. When the disease is detected at an early pre-invasive stage such as carcinoma in situ or high-grade dysplasia then endoscopic treatment is possible. Methods include removal by endoscopic mucosal resection or endoscopic submucosal dissection, and ablation using photodynamic therapy, argon plasma coagulation, laser ablation, cryotherapy, multipolar electrocoagulation or radiofrequency ablation.

 

 

 

 

3                      The procedure

3.1                  The aim of endoscopic radiofrequency ablation is to destroy squamous dysplasia in order to allow re-epithelialisation with normal squamous epithelium.

3.2                  The procedure is usually carried out with the patient under conscious sedation, in an outpatient setting. The area of squamous dysplasia is visualised using an endoscope. Spraying the oesophageal lining with Lugol’s iodine identifies areas of dysplasia that can otherwise be difficult to find. An appropriately sized radiofrequency ablation probe attached to the endoscope is inserted into the oesophagus, and advanced to the target area. Controlled pulses of radiofrequency energy are delivered, which cause thermal ablation of a thin layer of epithelium in the affected areas. A circumferential (360^°) ablation catheter is usually used for primary treatment, whereas a focal (90^°) ablation catheter can be used for remaining patches of squamous dysplasia in any subsequent treatments. Radiofrequency ablation can also be used after performing endoscopic mucosal resection to remove larger, superficial abnormal areas. If follow-up endoscopy and re-biopsy show residual changes, repeat treatment can be done using radiofrequency ablation.

 

 

 

 

4                      Efficacy

This section describes efficacy 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 interventional procedure overview.

4.1                  A case series of 29 patients (18 with moderate-grade squamous intra-epithelial neoplasia, 10 with high-grade squamous intra-epithelial neoplasia and 1 with early squamous cell carcinoma) treated by radiofrequency ablation reported that 86% (25/29) of patients had a complete response at 3 months and 97% (28/29) had a complete response at 12‑month follow-up.

4.2                  A case series of 20 patients (12 with squamous high-grade dysplasia and 8 with early squamous cell carcinoma confined to the mucosa) treated by radiofrequency ablation reported that in 50% (10/20) of patients there was complete reversal dysplasia at 12 months after a median of 1 treatment. Of these patients 80% (8/10) remained dysplasia free at a median follow-up of 24 months.

4.3                  The case series of 20 patients reported that 20% (2/10) of patients had a recurrence after initial successful radiofrequency ablation. In 1 patient this progressed to invasive cancer. The other patient had multifocal low-grade dysplasia and after 4 further radiofrequency ablation procedures still had low-grade dysplasia at 41‑month follow-up.

4.4                  The case series of 29 patients reported that there was no neoplastic progression (defined as detection of early oesophageal cell neoplasia of a more severe histological grade) at 12‑month follow-up.

4.5                  The case series of 20 patients reported that in 30% (6/20) of patients dysplasia progressed to invasive squamous cell cancer (defined as infiltration into the submucosal layer or beyond) at 1‑year follow-up.

4.6                  The specialist advisers listed key efficacy outcomes as eradication of squamous dysplasia and reduction in development of squamous carcinoma of the oesophagus.

 

 

 

 

 

5                      Safety

This section describes 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 interventional procedure overview.

5.1                  In a case series of 13 patients, 1 patient (with a narrowed oesophagus after endoscopic mucosal resection) had an oesophageal perforation and a mediastinal abscess that developed 2 days after dilation for stenosis, done 10 days after radiofrequency ablation. This was managed with a covered stent and percutaneous drainage. After removal of the stent a further stenosis was observed, which was treated by repeated dilatation, corticosteroid injection and incisional therapy.

5.2                  Oesophageal strictures were reported after circumferential radiofrequency ablation in 20% (4/20) and 14% (4/29) of patients in the case series of 20 and 29 patients. Two strictures (both related to endoscopic mucosal resection) were reported in 2 patients in the case series of 13 patients. All strictures in all these series resolved after 1 or more endoscopic dilations.

5.3                  Mucosal laceration after sizing was reported in 1 patient in the case series of 29 patients and in 1 patient in the case series of 20 patients. Mucosal laceration (at the endoscopic resection scar) was reported in 2 patients in the case series of 13 patients. None of these lacerations required treatment.

5.4                  Submucosal haematoma (asymptomatic, needing no intervention) was reported in 1 patient in the case series of 13 patients.

5.5                  The specialist advisers listed additional adverse events as dysphagia, odynophagia, complications of sedation, chest and back pain and progression to cancer.

 

 

 

 

6                      Committee comments

6.1                  The Committee noted contrasting outcomes in the available studies and was advised about the heterogeneous patient populations included in previous research.

6.2                  The Committee noted that many patients presenting with squamous dysplasia of the oesophagus are frail and that other treatment options (including oesophagectomy and chemoradiotherapy) may be unsuitable or pose high risks for them.

 

 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2014

 

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 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}