None listed
Conditions
Brief summary
This study is exploring two ways to take a sample(biopsy) from lung nodules that might be lung cancer. Method 1:a needle biopsy through chest wall, guided by a conventional Computed Tomography (CT) scan. This technique is widely used and usually gives good results, but it sometimes causes problems like collapsed lung or bleeding. Method 2: a newer technique using a thin camera (bronchoscope) guided into the lungs. This is done with the help of 'Cone Beam' CT, a special type of CT imaging that helps improve the accuracy of the bronchoscopic biopsy. We want to find out if Method Two (called Cone Beam Computed Tomography [CBCT] bronchoscopy) is as good as the traditional needle biopsy in terms of; getting a clear diagnosis and being safer for the patient. In this study, patients who need a lung biopsy and meet the criteria will be randomly assigned to have their biopsy using one of the two methods. We will compare how successful the two methods are, the duration, how much radiation they use, and any side effects. This is a small-scale version to test whether it’s practical to run a larger, full-scale study in the future. If this trial shows that CBCT bronchoscopy works well and is safer, it could become a more commonly used way to sample lung nodules, improving care for patients.
Interventions
The intervention for this study will be the randomisation of patients to either procedure
Method 2: Cone Beam CT–Guided Bronchoscopic Biopsy
Method 2 involves a bronchoscopic biopsy procedure performed using a thin flexible camera (bronchoscope) that is passed through the mouth and into the airways of the lungs to obtain tissue samples from a lung lesion.
The bronchoscope is inserted via the participant’s mouth under sedation or general anaesthesia and advanced through the trachea into the bron
The intervention for this study will be the randomisation of patients to either procedure Method 2: Cone Beam CT–Guided Bronchoscopic Biopsy Method 2 involves a bronchoscopic biopsy procedure performed using a thin flexible camera (bronchoscope) that is passed through the mouth and into the airways of the lungs to obtain tissue samples from a lung lesion. The bronchoscope is inserted via the participant’s mouth under sedation or general anaesthesia and advanced through the trachea into the bronchial tree. Cone Beam Computed Tomography (CBCT) imaging is used during the procedure to assist with localisation of the lung lesion and to guide biopsy instruments to the target area. The procedure is performed by a trained respiratory physician (interventional pulmonologist) with experience in advanced bronchoscopic techniques, supported by anaesthetic and radiography staff in a hospital procedure suite. The expected duration of the bronchoscopic procedure is approximately 45 to 90 minutes, including preparation and imaging time. Adherence to the intervention protocol will be assessed through procedure documentation in the medical record, including imaging confirmation of instrument position, procedural reports, and review of operative notes. Procedure details will be recorded prospectively for all participants.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults greater than or equal to 18 years • Presence of a peripheral pulmonary lesion deemed appropriate for biopsy by Macquarie University Hospital (MUH) Pulmonary Nodule Multi Disciplinary Meeting (MDM) • Medically fit to undergo either biopsy technique
Exclusion criteria
• Bleeding diathesis not correctable prior to procedure • Pregnant or breastfeeding • Inability to provide informed consent
Outcome results
None listed