Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal. There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy. Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield. In this study, investigators compare these two types of probes in the ability to diagnose a PPL. The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
88
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.
Middlemore Hospital, Counties Manakau District Health Board
Auckland, Auckland, New Zealand
RECRUITINGComparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as 1. To what biopsies give a diagnosis of malignancy and 2. Will decide what is the best sample in comparing all samples from both arms defined as " the highest number of malignant cells/hpf".
Time frame: 18 months
Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as to what is the best sample defined as " the sample most suitable for EGFR mutation analysis".
Time frame: 18 months
Compare the procedure related bleeding and pneumothorax rates between the two arms.
Time frame: 18 months
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