Endoscopic submucosal dissection of oesophageal dysplasia and neoplasia

# Guidance 
Current evidence on the efficacy of endoscopic submucosal dissection (ESD) in patients with oesophageal adenocarcinoma or high-grade dysplasia in Barrett's oesophagus is limited in quantity and there are safety concerns specifically regarding the risk of oesophageal perforation. Therefore, in these patients, the procedure should only be used in the context of research.
Current evidence on the efficacy of ESD in patients with oesophageal squamous carcinoma or squamous dysplasia is limited. This evidence is mostly from Japan where the epidemiology of oesophageal cancer is different from the UK. There are safety concerns specifically regarding the risk of oesophageal perforation. Therefore, in these patients, the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to undertake ESD for oesophageal squamous carcinoma or squamous dysplasia should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having ESD for oesophageal squamous carcinoma or squamous dysplasia (see section 3.1).
Patient selection should be carried out by an upper gastrointestinal cancer multidisciplinary team.
The procedure is technically challenging and should be carried out only by clinicians with specific training in the technique.
NICE encourages further research into the procedure. Studies should define clearly the type, grade and stage of cancer or dysplasia being treated. Efficacy outcomes should include adequacy of resection and the proportion of patients free from local recurrence. Safety outcomes should include perforation and stricture, and the consequences of these complications.# The procedure 

# Indications and current treatments
Malignant or premalignant changes in the oesophagus may take the form of either squamous cell carcinoma or adenocarcinoma, or their respective premalignant (dysplastic) forms. In the UK, approximately two thirds of all oesophageal cancers are adenocarcinomas and one third are squamous carcinomas.
Depending on the type and stage of cancer or dysplasia, current treatment options include oesophagectomy, chemotherapy, radiotherapy, ablative procedures such as radiofrequency ablation, and endoscopic mucosal resection (EMR). The latter usually removes lesions piecemeal, in contrast to ESD which aims to remove lesions intact and with a margin of healthy tissue.

# Outline of the procedure
ESD is usually preceded by diagnostic endoscopy, biopsy and imaging. The procedure is done with the patient under sedation or general anaesthesia. Under endoscopic visualisation, the submucosa is injected with saline to help lift the lesion. This fluid may contain pigment to help delineate the lesion, and adrenaline to reduce bleeding. A circumferential mucosal incision is made with an electrocautery knife around the lesion. Submucosal dissection is then carried out, parallel to the muscle layer, and the lesion is removed. A transparent hood can be used to retract the already dissected part of the lesion out of the visual field. Thermocoagulation is used to achieve haemostasis. Endoscopic clips can be used for larger vessels or to manage perforation.
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 comparative case series of 136 patients treated by ESD or by 1 of 2 different EMR techniques, reported en-bloc resection rates of 100% (31/31) for ESD, and 87% (59/68) and 71% (51/72) for the two EMR procedures (p < 0.05). A comparative case series of 77 patients treated by ESD or EMR reported en-bloc resection in 91% (29/32) and 11% (5/46) of lesions respectively. Case series of 84 and 43 patients (including 107 and 58 neoplastic or dysplastic squamous lesions, respectively) reported en-bloc resection of all lesions in both series, and R0 resection (both lateral and basal margins free) in 88% (94/107) and 78% (45/58) of lesions respectively.
The comparative case series of 77 patients treated by ESD or EMR reported local recurrence in 4% (1/26) and 25% (11/44) of patients respectively (follow-up and significance not stated).
The Specialist Advisers listed key efficacy outcomes as adequacy of cancer treatment (complete resection with clear margins on histology) and survival.

# Safety
Perforation during ESD causing pneumomediastinum was reported in 5% (4/84) of patients in the case series of 84 patients and 1 patient in the comparative case series of 136 patients (all successfully treated by antibiotics). Perforation with pneumomediastinum was reported in 7% (4/58) of lesion dissections in the case series of 43 patients: all were successfully treated by endoscopic clipping with the pneumomediastinum resolving spontaneously within a week.
Pneumomediastinum was reported in 6% (6/102) of cases in the series of 102, all successfully treated with antibiotics, fasting and intravenous infusion.
Oesophageal stricture was reported in 16% (9/58) of lesion dissections in the case series of 43 patients, all successfully treated by balloon dilatation.
In case series of 102 cases and 65 patients, oesophageal stenosis requiring balloon dilatation during follow-up was reported in 7% (7/102) of cases (mean follow-up 21 months) and 17% (11/65) of patients (follow-up of up to 47 months) respectively.
The Specialist Advisers considered possible adverse events to be aspiration pneumonia, uncontrollable bleeding and the need for emergency oesophagectomy.

# Other comments
The Committee considered that ESD could be suitable for a national register.# Further information
This guidance requires that clinicians undertaking ESD for oesophageal squamous carcinoma or squamous dysplasia make special arrangements for audit. NICE has identified relevant audit criteria and has 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.# About this guidance
NICE interventional procedure 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 NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
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
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.
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