Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal masses (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal masses

This procedure can be used for patients who are being tested for various diseases, including lung cancer. Under local or general anaesthesia, a thin flexible telescope (bronchoscope) is inserted via the patient's mouth into the lungs. Images of the region between the two lungs (the mediastinum) are obtained using an ultrasound probe attached to the bronchoscope. These images help to guide the operator when taking samples of cells from masses suspected of disease. The aim of the procedure is to help reach a diagnosis and, in patients with lung cancer, to establish whether the disease has spread beyond the lung.


The National Institute for Health and Clinical Excellence is examining endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal masses and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 needle aspiration (EBUS-TBNA) for mediastinal masses.

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 preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 Institute's 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 how it might be improved.

Closing date for comments: 20 November 2007
Target date for publication of guidance: February 2008


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for medastinal masses appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.
1.2 This procedure requires a combination of skills, and clinicians planning to undertake it should receive specific training.

 

2 The procedure
2.1 Indications
2.1.1 EBUS-TBNA is performed to investigate mediastinal masses, predominantly in the context of staging of non-small cell lung cancer. Other conditions associated with mediastinal lymphadenopathy include cancer of other organs, atypical infections and sarcoidosis.
2.1.2 After imaging studies (such as computer tomography [CT] and positron emission tomography [PET] scanning), histological investigation of mediastinal masses may be required. A variety of biopsy techniques may be used such as the conventional, non ultrasound-guided TBNA, transthoracic needle aspiration and endoscopic transoesophageal ultrasound-guided fine-needle aspiration (EUS-FNA). The latter involves insertion of an endoscope into the oesophagus and transoesophageal needle biopsy under ultrasound control. Occasionally mediastinoscopy or mediastinotomy may be required.
2.2 Outline of the procedure
2.2.1 EBUS-TBNA may be performed under local anaesthesia with sedation, or under general anaesthesia. A flexible bronchoscope containing an ultrasound probe is inserted via the trachea and guided through the bronchial tree towards the appropriate area of the mediastinum. The targeted lymph nodes or masses are identified using bronchoscopic visualisation and real-time ultrasound imaging. A needle extended from the bronchoscope through the bronchial wall is used to puncture the mass and to aspirate tissue. A mass can be punctured several times to gain an adequate sample, and several masses can be punctured during the same session.
2.3 Efficacy
2.3.1 A study of 502 patients compared the diagnostic performance of EBUS-TBNA with more invasive procedures (thoracotomy, thoracoscopy, mediastinoscopy) or clinical follow-up. The reported sensitivity and specificity for detecting lymph node malignancy was 94% and 100% respectively. The procedure was said to be 'accurate' if the patient's final diagnosis matched the EBUS-TBNA result. In this study, the accuracy of the procedure was 94%.
2.3.2 A case series of 108 patients compared EBUS-TBNA with final diagnosis based on EBUS-TBNA result plus clinical course or other pathological confirmation. The reported sensitivity, specificity and accuracy for detecting the correct lymph node stage was 95%, 100% and 96%, respectively.
2.3.3 Two studies of 102 and 33 patients compared EBUS-TBNA with final diagnosis based either on thoracotomy or clinical follow-up. In the first study, the reported sensitivity, specificity and accuracy for detection of malignancy was 92%, 100% and 98%, respectively. In the second study, the reported sensitivity, specificity and accuracy was 85% (95% confidence interval [CI]: 62 to 97), 100% (95% CI: 63 to 100) and 89% (95% CI: 72 to 98) respectively.
2.3.4 With regard to the accuracy of alternative techniques, the study of 102 patients compared CT scanning and PET scanning with final diagnosis based either on surgical staging or clinical follow-up. The reported sensitivity, specificity and accuracy was 77%, 55% and 61% respectively for CT and 80%, 70% and 73% respectively for PET. In the study of 33 patients, EUS-FNA was compared with final diagnosis based either on surgical staging or clinical follow-up, and the reported sensitivity, specificity and accuracy was 80%, 100% and 86%, respectively.
2.3.5 A study of 100 patients compared EBUS-TBNA with final diagnosis ascertained by surgery. The reported sensitivity and specificity for detecting lymph node malignancy was 92% and 100%, respectively.
2.3.6 A study of 65 patients with suspected sarcoidosis compared EBUS-TBNA against final diagnosis based on clinical and radiological findings, plus pathology and microbiological culture results from EBUS-TBNA or surgical biopsy. The reported sensitivity, specificity and accuracy was 88%, 100% and 88%, respectively.
2.3.7 A randomised controlled trial of 100 patients who had EBUS-TBNA and 100 patients who had conventional TBNA found that EBUS-TBNA successfully obtained a mediastinal lymph node aspirate (either positive or negative for malignancy) in 80% (80/100) of patients, compared with 71% (71/100) for conventional TBNA (p < 0.05). For more details, refer to the sources of evidence (see appendix).
2.3.8 The Specialist Advisers listed key efficacy outcomes as the ability to stage mediastinal malignancy, the quality and adequacy of pathological specimens and the diagnostic accuracy of EBUS-TBNA in comparison with CT scans, PET, mediastinoscopy or lung resection. One Adviser stated that the sensitivity of the procedure should be around 85%-90%.
2.4 Safety
2.4.1 One case series of 108 patients reported minor bleeding at the puncture site in some patients (no further information provided), but no other complications. The remaining six studies reported no complications. For more details, refer to the sources of evidence (see appendix).
2.4.2 The Specialist Advisers listed theoretical adverse events as hoarse voice, sore throat, cough, coughing up a small amount of blood, fever, significant bleeding, pneumothorax, pneumomediastinum, medastinitis and respiratory failure. One Adviser reported a case of asymptomatic pneumomedastinum.
2.5 Other comments
2.5.1 The Committee noted that some patients reported pain during EBUS-TBNA. Particular attention should therefore be paid to the use of analgesia during the procedure.
3 Further information
3.1 The Institute has published a clinical guideline on 'Lung cancer: diagnosis and treatment' (www.nice.org.uk/CG024).
   

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
October 2007

Appendix: Sources of evidence
 

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • 'Interventional procedure overview of endobronchial ultrasound-guided transbronchial needle aspiration for mediastinal masses', July 2007.

Available from: www.nice.org.uk/ip413overview.

This page was last updated: 30 March 2010