Randomised controlled trial of diagnosis and safety in bronchoscopic versus computed tomography (CT) guided biopsy for peripheral lung nodules.

INTERVENTION: Bronchoscopic Pre‐procedural bronchial branch tracing mapping. To be performed by respiratory physician prior to randomisation. Approximately 5‐10 minutes duration. Bronchoscopy performed with ultrathin bronchoscope (Olympus MP190F) with radial probe endobronchial ultrasound (Olympus UM‐S20‐17S). To be performed by experienced respiratory physician. Sampling to include peripheral transbronchial needle aspiration (pTBNA) with Olympus Periview Flex needle, +/‐ forceps/brush/wash. Approximate duration 30‐45 minutes. Procedure to be performed once only. CONDITION: Cancer ‐ Lung ‐ Non small cell peripheral lung nodule;lung cancer; ; peripheral lung nodule ; lung cancer Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: Difference in complication rate between bronchoscopic and CT guided sampling as assessed as binary outcome (yes/no), defined as any one of bleeding, pneumothorax, pneumonia, hospital admission, air‐embolism, respiratory failure or death within 7 days of procedure. To be prospectively collected and confirmed with documentation from patient medical record.; [1 week post procedure] Difference in diagnostic yield between bronchoscopic and CT guided sampling assessed by proportion of cases with definitive diagnosis on samples obtained by study procedure. Malignancy defined as a definite report of cancer. 'Suspicious' to be regarded as non‐diagnostic unless pathologist interpretation altered with additional clinico‐radiologic correlation at time of multi‐disciplinary lung cancer meeting. Benign lesions defined as those in whom working diagnosis from procedural sampling in keeping with end diagnosis on subsequent biopsy or on progress interval imaging of at least 6 months duration.[6 months post procedure] SECONDARY OUTCOME: Equipment cost, assessed by calculation of consumables utilised at each procedure, data to be collated at time of procedure. [Post procedure] Human resource use, to be assessed as number and role of individuals present at each procedure. Collated prospectively at time of procedure.[Post procedure] Procedural time as assessed by stopwatch commenced at time of patient entering procedure room and stopped at time of patient leaving procedure room.[Post procedure] INCLUSION CRITERIA: Presence of peripheral (outer 1/3 of lung field) lung nodule (1‐3cm) clinically requiring biopsy in whom both bronchoscopic and CT guided biopsy are considered feasible.