EBUS-TBNA vs Flex 19G EBUS-TBNA
Research type
Research Study
Full title
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
IRAS ID
191121
Contact name
Pallav Shah
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
There are a number of medical conditions that cause enlargement of glands (known as lymph nodes) in the mediastinum, the area in the centre of the chest between the lungs which contains the heart, large blood vessels, wind pipe and gullet. Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling these glands, but only provides needle aspirate samples which are often not adequate for advanced assessments of tissue samples, which is particularly important in the diagnosis of cancer.
Invasive surgical procedures such as mediastinoscopy, where a camera is passed behind the breast bone and requires a general anaesthetic and a hospital inpatient stay, is often necessary to obtain larger biopsy specimens. A new needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the end allowing better access to some lymph nodes and bigger specimens to be obtained.
Our centre already has experience of using this device in clinical practice, and our observations suggest that samples are larger than with the conventional needle, and the pathologists report that samples they receive in the laboratory are larger and of better quality. This allows them to more easily make a diagnosis, and also to run complex tests without resampling. This study aims to establish whether the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional needle, allowing more accurate diagnosis and reducing the need for repeat procedures or invasive surgical biopsies, without causing an increase in complications. Two hundred and fifty patients with enlarged lymph nodes will be randomised to have their nodes sampled by either the conventional needle or the novel Flex 19G EBUS-TBNA needle. The chance of being allocated to either procedure is the same.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/2057
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion