Endobronchial ultrasound-guided transbronchial biopsy for peripheral lung lesions - (Interventional Procedures Consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Endobronchial ultrasound-guided transbronchial biopsy for peripheral lung lesions
Lung lumps are commonly investigated using a thin flexible telescope (bronchoscope) inserted into the airways of the lung via the patient’s mouth or nose. Ultrasound-guided transbronchial biopsy is intended for diagnosing patients with a lung lump that cannot be reached by conventional bronchoscopy because the lump does not protrude into the airways. With the patient under local or general anaesthetic, a bronchoscope including an ultrasound probe is used instead of a conventional bronchoscope. Ultrasound images of the lung are obtained through the bronchoscope and these help to guide the doctor to the location of the lump, to obtain samples for further tests.
The National Institute for Health and Clinical Excellence (NICE) is examining endobronchial ultrasound-guided transbronchial biopsy for peripheral lung 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 endobronchial ultrasound-guided transbronchial biopsy for peripheral lung 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.
If you wish to comment on the consultation document please use the link at the bottom of this page.
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 how it might be improved.
If you wish to be alerted to developments regarding this procedure, including the release of NICE guidance, please express your interest at the top of the page.
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 the efficacy of ultrasound-guided transbronchial biopsy (EBUS–TBB) for peripheral lung lesions supports the efficacy of the procedure in producing a high diagnostic yield. With regard to safety, there is an incidence of false negative results in malignant disease, so negative or inconclusive specimens should be further investigated using other biopsy techniques. The procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.
1.2 This procedure should only be carried out by a bronchoscopist who has had specific training and mentoring in the technique.
2 The procedure
2.1 Indications and current treatments
2.1.1 In this guidance, ‘peripheral lung lesions’ describes lung lesions that cannot be visualised using conventional bronchoscopy because they do not protrude into the bronchial tree. This guidance is concerned only with the diagnosis of such lesions, and not with their treatment.
2.1.2 Patients with peripheral lung lesions usually present with cough, haemoptysis, shortness of breath and weight loss, which prompt radiological and bronchoscopic investigations. Establishing whether a lesion is benign or malignant requires a biopsy.
2.1.3 Current biopsy techniques include blind transbronchial lung biopsy, image-guided percutaneous lung biopsy, or (thoracoscopic or open) surgical biopsy.
2.2 Outline of the procedure
2.2.1 The procedure can be undertaken with the patient under general anaesthesia or under local anaesthesia with or without sedation. The lesion is identified by prior computed tomography (CT), positron emission tomography (PET) or conventional chest X-ray imaging. A flexible fibreoptic bronchoscope with a radial mini-probe or catheter is inserted through the nose or mouth, and advanced towards the peripheral lung lesion using endobronchial ultrasound (EBUS) guidance. Once the bronchoscope is in the appropriate location the ultrasound mini-probe or catheter is withdrawn and biopsy forceps or needles are introduced into the working channel to obtain a histological sample of the target lesion, with or without fluoroscopic guidance. Use of a guide sheath can help to keep the bronchoscope in place during the removal of the probe and insertion of biopsy instruments.
| 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/IP666overview. |
2.3 Efficacy
2.3.1 A randomised controlled trial (RCT) of 293 patients investigated by TBB with or without EBUS guidance reported a diagnostic yield of 79% (48/61) for malignant lesions and 69% (18/26) for benign lesions in the EBUS–TBB group compared with 55% (46/83) and 44% (16/36) in the TBB-alone group (without EBUS guidance).
2.3.2 An RCT of 202 patients investigated by EBUS transbronchial needle aspiration (TBNA) plus TBB plus bronchial washing (BW) or EBUS–TBB plus BW, reported a diagnostic yield of 78% (69/88) and 61% (57/94) respectively (p = 0.015). Without EBUS guidance the diagnostic yield was 63% (55/88) for TBNA, 49% (89/182) for TBB (p = 0.049 compared with TBNA) and 20% (36/182) for BW (p < 0.001 compared with TBNA).
2.3.3 An RCT of 120 patients investigated by EBUS–TBB, or electromagnetic navigation bronchoscopy (ENB)–TBB, or a combination of EBUS/ENB–TBB reported a diagnostic yield of 69% (27/39), 59% (23/39) and 88% (35/40), respectively (p = 0.02 for comparisons between the groups).
2.3.4 A non-randomised comparative study of 261 diagnostic procedures using EBUS–TBB (using a guide sheath [GS]) or percutaneous CT-guided fine needle aspiration (CT–FNA) reported sensitivity values of 66% (93/140) and 64% (77/121), respectively (significance not stated).
2.3.5 The Specialist Advisers listed key efficacy outcomes as diagnostic yield, sensitivity, specificity, positive and negative predictive values, avoidance of CT-guided procedures (that is, reducing radiation exposure for the patient) and patient acceptability.
2.4 Safety
2.4.1 An RCT of 120 patients reported pneumothorax in 5% (2/39) of the EBUS–TBB group, 5% (2/39) of the ENB–TBB group and 8% (3/40) of the combined EBUS/ENB–TBB group; 4 patients were treated with chest drain insertion and 1 was managed with aspiration and observation. The other 2 patients were managed by observation and supplemental oxygen.
2.4.2 Pneumothorax was reported in 1% (2/140) of patients in the EBUS–GS TBLB group compared with 22% (27/121) of patients in the percutaneous CT–FNA group (p < 0.01) in the non-randomised comparative study of 261 procedures.
2.4.3 Pneumothorax was reported in 3% (3/119) of patients in the TBB-alone group compared with none of the patients in the EBUS–TBB group in the RCT of 293 patients. Pneumothorax determined by chest radiograph taken 1 to 2 hours after the procedure was reported in 2% (2/88) of patients in the EBUS–TBNA plus TBB plus BW group and 2% (2/94) of patients in the EBUS–TBB plus BW group in the RCT of 202 patients.
2.4.4 The RCT of 293 patients reported bleeding in none of the patients in the EBUS-TBB group compared with 6% (7/119) of patients in the TBB-alone group. The RCT of 202 patients reported bleeding in 5% (4/88) of patients in the EBUS–TBNA plus TBB plus BW group compared with 2% (2/94) of patients in the EBUS–TBB plus BW group. The non-randomised comparative study of 261 procedures reported bleeding in 1% (1/140) of patients in the EBUS–GS TBLB group compared with 3% (4/121) of patients in the percutaneous CT–FNA group.
2.4.5 The Specialist Advisers listed adverse events reported in the literature as pneumothorax and haemorrhage. They listed a theoretical adverse event as false negative rate.
2.5 Other comments
2.5.1 The Committee noted the risk of false negative results using this procedure. Any negative or inconclusive findings should be investigated using other biopsy procedures.
3 Further information
3.5.1 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.
3.5.2 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