Interventional procedure consultation document

Endoscopic submucosal dissection of oesophageal dysplasia and neoplasia

This procedure can be used to treat abnormalities in the lining of the oesophagus. A long camera (endoscope) is inserted through the mouth and into the oesophagus to view the affected area. A solution is injected into the wall of the oesophagus, and then the abnormal part of its lining is removed with special instruments. The aim of the procedure is to 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 for oesophageal dysplasia and neoplasia 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 for oesophageal dysplasia and neoplasia.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 16 June 2010

Target date for publication of guidance: September 2010

1    Provisional recommendations

1.1  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.

1.2  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.

1.3  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 (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

·      Audit and review clinical outcomes of all patients having ESD for oesophageal squamous carcinoma or squamous dysplasia (see section 3.1).

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

1.5  The procedure is technically challenging and should be carried out only by clinicians with specific training in the technique.

1.6  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.

2    The procedure

2.1  Indications and current treatments

2.1.1  Malignant or premalignant change 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.

2.1.2  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.

 

2.2    Outline of the procedure

2.2.1  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 fluid to help lift the lesion. This fluid may contain sodium hyaluronate, small quantities of pigment dye to help better delineate the lesion’s border, 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 may be used to retract the already dissected part of the lesion out of the field of view. 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, available at www.nice.org.uk/IP840overview

2.3    Efficacy

2.3.1  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 in 88% (94/107) and R0 resection (both lateral and basal margins free) in 78% (45/58) of lesions.

2.3.2  The comparative case series of 136 patients treated by ESD or by 1 of 2 different EMR techniques reported curative resection rates of 97% (30/31) for ESD, and 71% (48/68) and 46% (33/72) for the 2 EMR procedures (p < 0.05).

2.3.3  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 interval and significance not stated).

2.3.4  The Specialist Advisers listed key efficacy outcomes as adequacy of cancer treatment (complete resection with clear margins on histology) and survival.

2.4    Safety

2.4.1  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 lesions in the case series of 43 patients: successfully treated by endoscopic clipping with the pneumomediastinum resolving spontaneously within a week in all cases.

2.4.2  Pneumomediastinum was reported in 6% (6/102) of cases in the series of 102, successfully treated with antibiotics, fasting and intravenous infusion.

2.4.3  Oesophageal stricture was reported in 16% (9/58) of lesions in the case series of 43 patients, all successfully treated by balloon dilatation.

2.4.4  In case series of 102 cases and 65 patients, oesophageal stenosis requiring balloon dilatation during follow-up of up to 47 months and a mean of 21 months was reported in 7% (7/102) and 17% (11/65) of patients respectively.

2.4.5  The Specialist Advisers considered possible adverse events as aspiration pneumonia, uncontrollable bleeding and the need for emergency oesophagectomy.

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.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee
April 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.}