Interventional procedure consultation document

Endoscopic submucosal dissection of gastric lesions

This procedure can be used to treat abnormalities on the wall of the stomach. A long camera (endoscope) is inserted through the mouth, oesophagus and into the stomach to view the affected area. A solution is injected into the wall of the stomach, and then the part of the stomach wall that looks abnormal is removed with special instruments. The aim of the procedure is to help avoid the need for open surgery, and to obtain a good quality sample for examination under the microscope.

The National Institute for Health and Clinical Excellence (NICE) is examining endoscopic submucosal dissection of gastric lesions and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. 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 submucosal dissection of gastric lesions.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. 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: 23 June 2010

Target date for publication of guidance: September 2010

1   Provisional recommendations

1.1   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.

1.2   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 (available from www.nice.org.uk/guidance/IPGXXXpublicinfo).
• Audit and review clinical outcomes of all patients having ESD of gastric lesions (see section 3.1).

1.3   Patient selection should be carried out by an upper gastrointestinal cancer multidisciplinary team.

1.4   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.

1.5   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.

2   The procedure

2.1   Indications and current treatments

2.1.1   Gastric lesions may include different types of benign, dysplastic, and malignant tumours. Patients may be asymptomatic or experience loss of appetite and weight, anaemia and abdominal discomfort or pain.

2.1.2   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.

2.2   Outline of the procedure

2.2.1   ESD aims to remove lesions without the need for open abdominal surgery. ESD is usually preceded by diagnostic endoscopy, biopsy and imaging investigations.

2.2.2   The procedure is carried out with the patient under sedation or general anaesthesia. Using endoscopic visualisation, the submucosa is injected with saline fluid to help lift the lesion. This fluid may contain sodium hyaluronate, small quantities of pigment dye to help define the edge of 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 field of view. 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, available at www.nice.org.uk/guidance/IP767/overview

2.3   Efficacy

2.3.1   A non-randomised comparative study of 900 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.

2.3.2   A non-randomised comparative study of 896 patients (1020 lesions) reported a significantly greater complete en-bloc resection rate for non-ulcerated lesions of 93% (157/169) for ESD compared with 43% (343/790) for EMR and histological resection rates (histologically clear margins) of 93% (157/169) vs 25% (194/790) respectively; p < 0.01.

2.3.3   A case series of 59 lesions (patient numbers not stated) reported en-bloc resection by ESD in 86% (44/51) and complete resection with both lateral and basal margins free in 73% (37/51).

2.3.4   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).

2.3.5   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) and 4% (21/478) in EMR-treated patients with en-bloc resection and piecemeal resection respectively over a mean 83.2-month follow-up.

2.3.6   The case series of 59 patients reported local recurrence in 5 patients treated by piecemeal ESD at up to 8-month follow-up.

2.3.7   The Specialist Advisers listed key efficacy outcomes as en-bloc and curative resection rates, recurrence rate and survival.

2.4   Safety

2.4.1   The non-randomised studies of 900 lesions and 346 patients reported perforation in 4% (20/572) and 5% (11/243) of ESD-treated patients, and 2% (5/328) and 2% (2/103) of EMR-treated patients respectively (differences reported as not significant). In the study of 346 patients, 3 of the perforations in ESD-treated patients and 1 in an EMR-treated patient were detected during the procedure but the other perforations were recognised postoperatively (timing not stated). All the perforations following ESD were managed non-surgically with a combination of endoscopic clipping, fasting, nasogastric tube drainage and antibiotics. 

2.4.2   The non-randomised study of 655 patients (714 lesions) reported that perforation was significantly more frequent in ESD-treated patients than in EMR-treated patients (4% [11/303] vs 1% [5/411] lesions) (p < 0.05). All patients were managed endoscopically (not otherwise described).

2.4.3   The Specialist Advisers listed bleeding as an anecdotal adverse event and considered the theoretical risk of perforation leading to tumour feeding.

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

May, 2010

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

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