Endoscopic submucosal dissection of gastric lesions

# Guidance
Current evidence on the safety and efficacy of endoscopic submucosal dissection (ESD) of gastric lesions shows that it is efficacious in achieving complete resection in a high proportion of cases, but evidence of long-term survival following treatment of malignant lesions is limited in quantity. There are safety concerns regarding the risks of perforation and bleeding. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to undertake ESD of gastric lesions should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's efficacy in relation to treating malignant lesions; and the risks of perforation, bleeding, and possible conversion to open surgery. Patients should be provided 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 of gastric lesions (see section 3.1).
Patient selection should be carried out by an upper gastrointestinal cancer multidisciplinary team.
This is a technically challenging procedure and should only be carried out by clinicians with specific training in the technique. The Joint Advisory Group on Gastrointestinal Endoscopy intends to prepare training standards for this procedure.
NICE encourages further research into ESD of gastric lesions. There should be clear documentation of the incidence of complications, including perforation, bleeding and the need for open surgery (with the reasons for this), rates of complete resection, and long-term outcomes, including local recurrence and survival following treatment of malignant lesions.# The procedure

# Indications and current treatments
Gastric lesions include benign, dysplastic, and malignant tumours. Patients may be asymptomatic or experience loss of appetite and weight, anaemia and abdominal discomfort or pain.
Current treatment options for small gastric lesions are snare polypectomy (for protruding lesions) or endoscopic mucosal resection (EMR) (for 'flat' lesions). EMR usually removes lesions piecemeal; in contrast, ESD aims to remove lesions intact and with a margin of healthy tissue.

# Outline of the procedure
Endoscopic submucosal dissection aims to remove lesions without the need for open abdominal surgery. It is usually preceded by diagnostic endoscopy, biopsy and imaging investigations.
The procedure is carried out with the patient under sedation or general anaesthesia. Using endoscopic visualisation, the submucosa is injected with saline to help lift the lesion. This fluid may contain a pigment to help define 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, aiming to remove the lesion intact and with a healthy margin of tissue. A transparent hood may be used to retract the already dissected part of the lesion out of the visual field. Haemostasis is achieved by electrocautery. Endoscopic clips may 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 non-randomised comparative study of 900 malignant lesions (patient numbers not stated) reported significantly greater complete resection rates of 95% (544/572) for ESD vs 64% (210/328) for EMR, and curative (with tumour-free margins) resection rates of 83% (473/572) vs 59% (195/328) respectively; p < 0.05 for both comparisons.
A non-randomised comparative study of 896 patients (1020 malignant lesions) reported significantly greater complete en-bloc resection rates for non-ulcerated lesions of 93% (157/169) for ESD compared with 43% (343/790) for EMR, and histologically clear margin resection rates of 93% (157/169) vs 25% (194/790) respectively (p < 0.01).
A case series of 59 premalignant or malignant lesions (patient numbers not stated) reported en-bloc resection by ESD in 86% (44/51) and free-margin complete resection in 73% (37/51) of lesions.
The non-randomised comparative study of 900 lesions reported no recurrence among ESD-treated lesions and recurrence in 4% (13/328) of EMR-treated lesions (p < 0.05).
The non-randomised comparative study of 896 patients reported no recurrence in ESD-treated patients at a mean 19.4-month follow-up, and recurrence rates of 3% (10/347) in ESD-treated patients and 4% (21/478) in EMR-treated patients during 83.2-month follow-up.
The case series of 59 lesions reported local recurrence in 5 patients treated by piecemeal ESD at up to 8-month follow-up.
The Specialist Advisers listed key efficacy outcomes as en-bloc and curative resection rates, recurrence rate and survival.

# Safety
Two non-randomised studies  1 of 900 lesions and the other of 346 patients  reported perforation in 4% (20/572) and 5% (11/243) of ESD-treated lesions or patients, and 2% (5/328) and 2% (2/103) of EMR-treated lesions or patients respectively (differences reported as not significant). In the study of 346 patients, 3 perforations in ESD-treated patients and 1 in an EMR-treated patient were detected intraprocedurally but the others were recognised post-procedurally (timing not stated). All perforations following ESD were managed non-surgically with a combination of endoscopic clipping, fasting, nasogastric tube drainage and antibiotics.
A non-randomised study of 655 patients (714 lesions) reported that perforations were significantly more frequent in ESD-treated patients than in EMR-treated patients (4%  vs 1%  of lesions) (p < 0.05). All patients were managed endoscopically (not otherwise described).
The Specialist Advisers listed bleeding as an anecdotal adverse event and considered the theoretical risk of perforation leading to tumour seeding.

# Other comments
The Committee considered that ESD could be suitable for a national register.# Further information
This guidance requires that clinicians undertaking the procedure 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. A large print version is also available.# 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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