Interventional procedure consultation document

Endoscopic mucosal resection and endoscopic submucosal dissection of non-ampullary duodenal lesions

This procedure can be used to treat abnormalities in the lining of the part of the small intestine near the stomach (the duodenum). A long camera (endoscope) is inserted through the mouth, oesophagus and stomach to view the affected area. A solution is injected into the wall of the duodenum, and then the abnormal parts of the lining are 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 mucosal resection and endoscopic submucosal dissection of non‑ampullary duodenal 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 mucosal resection and endoscopic submucosal dissection of non-ampullary duodenal 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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   The evidence on efficacy of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) of non-ampullary duodenal lesions is limited in quantity and there are safety concerns regarding the risks of perforation and bleeding. Therefore these procedures should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake EMR and ESD of non-ampullary duodenal lesions should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about these procedures’ safety and efficacy in relation to the risks of perforation and bleeding, and that conversion to open surgery may be necessary. 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 EMR and ESD of non-ampullary duodenal lesions (see section 3.1).

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

1.4   Both EMR and ESD of non-ampullary duodenal lesions are technically challenging procedures and should be carried out only by clinicians with specific training and expertise in the use of EMR and ESD in other parts of the gastrointestinal tract (where lesions are more common). The Joint Advisory Group on Gastrointestinal Endoscopy intends to prepare training standards on these procedures.

1.5   NICE encourages further research into EMR and ESD of non‑ampullary duodenal 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   Duodenal lesions are rare. They include benign, dysplastic or neoplastic (malignant) lesions. Some patients have inherited polyposis syndromes (such as familial adenomatous polyposis). Patients may be asymptomatic, or may experience nausea and vomiting, loss of appetite and weight, anaemia and abdominal pain. In patients with familial polyposis, lesions may be identified through regular surveillance examinations.

2.1.2   Current treatment of malignant lesions usually involves major surgery (Whipple procedure). Endoscopic treatments such as snare polypectomy and argon plasma coagulation (APC) have been used as options for smaller lesions.

2.2   Outline of the procedure

2.2.1   Both EMR and ESD aim to remove lesions without the need for open abdominal surgery. They are usually preceded by diagnostic endoscopy, biopsy and imaging investigations.

2.2.2   Both EMR and ESD are 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. In EMR, the lesion is usually removed piecemeal with a snare. In ESD, submucosal dissection is performed with an electrocautery knife, parallel to the muscle layer, aiming to remove the lesion intact and with a margin of healthy 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/IP841/overview

2.3   Efficacy

2.3.1   Case series of 27, 23 and 3 patients reported complete resection in 85% (23/27), 86% (18/21) and 100% (3/3) of EMR‑treated patients respectively. A case series of 14 patients reported that all 9 ESD-treated lesions were resected en bloc and 5 of the 6 EMR-treated patients were resected en bloc. 

2.3.2   The case series of 23 patients (21 EMR-treated patients) reported no local recurrences among 8 lesions removed en bloc at a median 13-month follow-up. Among 13 lesions removed piecemeal, 39% (5/13) of lesions had remnant adenoma at median follow‑up of 10 months. All were treated successfully; 3 by snare resection and APC, 2 with APC alone.

2.3.3   Case series of 13 EMR-treated patients, 4 ESD-treated patients and 3 EMR-treated patients reported no deaths or recurrences at mean follow-ups of 51.7 months, 18 months and 21.5 months.

2.3.4   The Specialist Advisers listed key efficacy outcomes as complete removal and recurrence rates, recovery period and mortality.

2.4   Safety

2.4.1   Perforation was reported in 2 ESD-treated patients (no perforation among EMR-treated patients) and 2 ESD-treated patients (successfully managed conservatively) in the case series of 14 and 4 patients respectively.

2.4.2   Bleeding was reported in 33% (9/27) of patients in the case series of 27 EMR-treated patients. These cases were within a larger case series of 92 patients who had EMR in various parts of the gastrointestinal tract. Among the 92 patients, 22 developed bleeding: 73% (16/22) early (within 24 hours of EMR treatment) and 27% (6/22) later. Among those who bled early, 88% (14/16) were treated with endoscopic clip placement, ligation with a snare, electrocoagulation and/or injection therapy:  33% (2/6) of those who bled later required endoscopic management. Blood transfusion was required in 14% (3/22) of patients.

2.4.3   Postoperative bleeding was reported in 2 of 9 ESD-treated patients and 1 of 5 EMR-treated patients in the case series of 14 patients. All were successfully treated using endoscopic clips. The case series of 23 and 13 patients reported that 1 patient in each series developed bleeding after EMR (1 occurred up to 48 hours after EMR, the other timing was not described); both were successfully treated using endoscopic clips.

2.4.4   The Specialist Advisers considered theoretical adverse events to include delayed haemorrhage, perforation, bleeding and pain. They stated that the risks of perforation and bleeding are higher when these procedures are used in the duodenum than in other parts of the gastrointestinal tract.

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.}