None listed
Conditions
Brief summary
This study is aiming to determine whether one of two needles (that are approved by the Therapeutics and Goods Administration) is better than the other for taking samples from mediastinal (chest) lymph nodes for the diagnosis of lung cancers. Who is it for? You may be eligible for this study if you are aged 18 or older and you have been referred by your doctor to undergo a chest lymph node biopsy procedure known as Transbronchial Node Aspiration by Endoscopic Ultrasound. Participants may have a known cancer diagnosis or will be undergoing this procedure to determine a final diagnosis such as, but not limited to, lung cancer, sarcoidosis or tuberculosis. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin), to undergo a biopsy by one needle (Acquire), or the other (ViziShot). The biopsy procedure will involve giving anaesthetics then examining airways using a camera passed via vocal cords. Both procedures will be the same, the only difference will be which needle is used. 7- 10 days after the procedure, a member of the research team will phone all participants to check if they have experienced any side effects potentially related to the procedure, including going to the emergency department. It is hoped this research will determine whether one needle is superior to the other, and this may then improve current practice by reducing the number of biopsies needed.
Interventions
Exposure: patients whose mediastinal lymph node sample was taken using Acquire Needle (manufacturer: Boston Scientific).
All patients who are referred to mediastinal/hilar lymph node sampling will be screened. Sampling is done by interventional pulmonologists and there are 2 needs available to taking samples.
We denoted Acquire needle (Boston Scientific) as "interventional" as it is newer but technically we are not intervening but rather comparing 2 methods of obtaining samples. Acquire needle
Exposure: patients whose mediastinal lymph node sample was taken using Acquire Needle (manufacturer: Boston Scientific). All patients who are referred to mediastinal/hilar lymph node sampling will be screened. Sampling is done by interventional pulmonologists and there are 2 needs available to taking samples. We denoted Acquire needle (Boston Scientific) as "interventional" as it is newer but technically we are not intervening but rather comparing 2 methods of obtaining samples. Acquire needles have 3 cut points and pierces lymph nodes easier. The procedure usually takes 45 min (including anaesthesia, examining bronchi then examining lymph nodes and taking samples). All procedures are done by an interventional pulmonologist or a trainee under direct supervision.
Sponsors
Dr Moayed Alawami
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients referred to Transbronchial Node Aspiration (TBNA) by Endoscopic Ultrasound (EBUS) that meet the following criteria: - Adults (defined as older than or equal to 18 years of age). There is no upper limit of age provided participants can consent. - Outpatient/Elective admission to perform the procedure - Not on anticoagulation (or withheld prior to procedure). Aspirin is ok - Able to consent - First TBNA (linear) EBUS (not a redo procedure and no linear EBUS with last 8 weeks). - Repeat EBUS due to participants intolerance is considered to be failure of bronchoscopy/sedation rather than failure of biopsy needle. The failed procedure results will be not be counted - At least 1 lymph node size greater or equal to 10 mm
Exclusion criteria
- Unable to consent, this includes but not limited to participants with dementia, intellectual difficulties, or inability to communicate. - Contraindication to taking biopsy – ie on anticoagulation or dual antiplatelets therapy within 48 hrs of procedure or INR > 1.5 - Inpatients (due to being sick, likely less time to consider participation and making an informed consent). To clarify, inpatients refer to patients who were admitted via emergency department and does not include elective admission to facilitate a procedure or investigations such as who live far away from Lyell McEwin Hospital.
Outcome results
None listed