Endoscopic submucosal dissection of lower gastrointestinal lesions (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Endoscopic submucosal dissection of lower gastrointestinal lesions

This procedure can be used to treat abnormalities on the wall of the bowel. A long camera (colonoscope) is inserted into the bowel to view the affected area. A solution is injected into the wall of the bowel, and then the part of the bowel 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 examining the abnormality under the microscope.

The National Institute for Health and Clinical Excellence (NICE) is examining endoscopic submucosal dissection of lower gastrointestinal 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 lower gastrointestinal 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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 21 December 2009

Target date for publication of guidance: March 2010

 

1       Provisional recommendations

1.1  Current evidence on endoscopic submucosal dissection (ESD) of lower gastrointestinal lesions shows that it is efficacious, but evidence on long-term survival when used to treat malignant lesions is limited in quantity. There are some concerns about safety with regard to the risk 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 lower gastrointestinal lesions should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the uncertainty about the procedure’s 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/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having ESD of lower gastrointestinal lesions (see section 3.1).

1.3  Endoscopic submucosal dissection of lower gastrointestinal lesions is a technically challenging procedure and should only be carried out by clinicians with specific training in the technique.

1.4  Patient selection should be carried out either by a colorectal surgeon who is experienced in the technique or by both a colorectal surgeon and an endoscopist experienced in this technique.. 

1.5  Further research would be useful. There should be clear documentation of the incidence of complications including perforation, haemorrhage and the need for open surgery (with the reasons for this), rates of complete resection, and long-term outcomes including local recurrence and survival.

2       The procedure

2.1    Indications and current treatments

2.1.1  Colorectal lesions may be benign, premalignant or malignant. Patients may be asymptomatic or may present with blood in the stool, change in bowel habit, abdominal pain or unexplained weight loss. 

2.1.2  Lower gastrointestinal lesions may be investigated radiologically and/or endoscopically. Treatment normally involves resection of the lesions, which may be performed endoscopically or surgically. Current management of small colorectal lesions usually involves snare polypectomy (for lesions protruding into the bowel lumen) or endoscopic mucosal resection (EMR) (for laterally spreading or ‘flat’ lesions). EMR usually removes lesions in a piecemeal fashion, while ESD aims to resect lesions intact.

2.2    Outline of the procedure

2.2.1  In ESD, an electrocautery knife is used to dissect the lesion in one piece (en bloc). This aims to reduce the risk of recurrence and to allow more accurate histopathological assessment.

2.2.2  The procedure is usually performed with the patient under sedation but general anaesthesia may be used. The lesion is visualised at colonoscopy and the submucosa is injected with fluid to raise the lesion away from it. The fluid usually contains sodium hyaluronate, with or without a pigment dye (to help delineate the lesion), and adrenaline (to reduce bleeding).

2.2.3  An initial circumferential mucosal incision is made around the lesion with the electrothermal knife. Submucosal dissection is then performed under endoscopic visualisation, parallel to the muscle layer. Diathermy coagulation is used to achieve haemostasis, but in addition, endoclips may be required to control bleeding and/or treat small perforations.

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/IP775overview.

 

2.3    Efficacy

2.3.1  A systematic review of 14 studies including 1314 patients reported en bloc lesion resection rate of 85% and complete cure (en bloc resection with histologically clear margins) of 75% (follow-up not stated).

2.3.2  Case series of 361 lesions, and of 166, 42 and 35 patients, reported en bloc resection rates of 95% (355/373), 80% (133/166), 79% (33/42) and 89% (31/35), respectively. In the case series of 42 and 35 patients, en bloc resections included completely free (lateral and basal) margins in 74% (31/42)and 63% (22/35) of patients, respectively.

2.3.3  Local recurrence (whether the lesion was malignant is not explicitly stipulated in the paper) was reported in 1 patient in a case series of 198 patients at a median follow-up of 220 days.

2.3.4  Case series of 198, 186, 42 and 35 patients reported local recurrence in 0.5% (1/198), 2% (2/111) (malignant), 5% (2/42) (malignant) and 3% (1/35) of patients (at median follow-ups of 220 days, and 18 months, and 6-month and 2-month follow-up, respectively) (lesions not otherwise described).

2.3.5  The Specialist Advisers listed key efficacy outcomes as one-piece resection rate (providing a definitive histological specimen), complete resection rate with clear margins, endoscopic cure rate, clinical cure rate and avoidance of surgery.

2.4    Safety

2.4.1  The case series of 361 lesions reported a perforation rate of 2% (7/361): 6 of the 7 perforations were detected during the procedure; 5 of the 7 were managed ‘conservatively’ (not otherwise described), while 2 patients required surgical repair. A case series of 198 patients (200 lesions) reported a colonic wall perforation rate of 5% (10/200): all 10 perforations were detected during the procedure, 9 were managed successfully with application of endoscopic clips insertion and 1 required open surgical repair. In a case series of 186 patients (200 lesions) a perforation rate of 6% (12/200) was reported: 11 of the perforations were detected during the procedure and 1 was detected 2 days later (it required open surgical repair). Perforations occurred in 14% (6/43) of patients treated by ESD in an audit of 43 ESD-treated patients (no further details).

2.4.2  The case series of 186 patients reported rectal bleeding, which prompted emergency colonoscopy for application of endoclips in 1% (2/200) of patients. One bleed occurred on the day of the procedure and the other was 10 days later.

2.4.3  Acute intestinal obstruction 18 hours after the procedure was reported in a case report of 1 patient (treated by aggressive fluid resuscitation and colonoscopic decompression).

2.4.4  The Specialist Advisers reported an anecdotal adverse event of transient abdominal pain during the procedure. They considered theoretical adverse events to include conversion of a curable cancer to an incurable cancer because of perforation.

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
November 2009

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

This page was last updated: 30 March 2010