Endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus

# Recommendations
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 wellrecognised complications, particularly oesophageal strictures. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
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 is recommended.
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.
Endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus should only be done by endoscopists experienced in treating oesophageal dysplasia.
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.
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.# Indications and current treatments
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 intraepithelial neoplasia (defined as noninvasive cytological or architectural alterations that may lead to development of invasive cancer) and categorises it as either low or highgrade. Lowgrade squamous dysplasia is associated with a low risk of progression to invasive squamous cell carcinoma, whereas highgrade intraepithelial neoplasia carries a higher risk of progression.
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 preinvasive stage such as carcinoma in situ or highgrade 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 or multipolar electrocoagulation.# The procedure
The aim of endoscopic radiofrequency ablation is to destroy squamous dysplasia in order to allow reepithelialisation with normal squamous epithelium.
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 cells in the affected areas. A circumferential ablation catheter is usually used for primary treatment, whereas a focal ablation catheter can be used for remaining patches of squamous dysplasia in any subsequent treatments. Radiofrequency ablation can also be used after doing endoscopic mucosal resection to remove larger, superficial abnormal areas. If followup high resolution endoscopy and rebiopsy show residual changes, repeat treatment can be done using radiofrequency ablation.# 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.
A case series of 29 patients (18 with moderategrade squamous intraepithelial neoplasia, 10 with highgrade squamous intraepithelial neoplasia and 1 with early squamous cell carcinoma) treated by radiofrequency ablation reported complete response (defined as absence of disease from any biopsy in the treatment area) in 86% (25/29) of patients at 3 months and 97% (28/29) of patients at 12month followup.
A case series of 20 patients (12 with squamous highgrade 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 of dysplasia at 12 months after a median of 1 treatment. Of these patients, 80% (8/10) remained free of dysplasia at a median followup of 24 months.
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 lowgrade dysplasia and after 4 further radiofrequency ablation procedures still had lowgrade dysplasia at 41month followup.
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 12month followup.
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 1year followup.
The specialist advisers listed key efficacy outcomes as eradication of squamous dysplasia and reduction in development of squamous carcinoma of the oesophagus.# 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.
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 12 days after radiofrequency ablation. This was managed with a covered stent and percutaneous drainage. After removal of the stent, a further stenosis was observed that was treated by repeated dilatation, corticosteroid injection and incisional therapy.
Oesophageal strictures were reported after circumferential radiofrequency ablation in 20% (4/20) and 14% (4/29) of patients in a case series of 20 patients and a case series of 29 patients respectively. 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.
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 needed treatment.
Submucosal haematoma (asymptomatic and needing no intervention) was reported in 1 patient in the case series of 13 patients.
The specialist advisers listed additional adverse events as complications of sedation, odynophagia, dysphagia, and chest and back pain.# Further information
For related NICE guidance see the NICE website.

# Information for patients
NICE has produced information on this procedure for patients and carers. It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.
ISBN 978-1-4731-0654-3