Pulmonary Parenchymal Lesions
Conditions
Keywords
Diagnosis
Brief summary
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)
Interventions
PROCEDURERadial EBUS biopsy
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
DEVICETypes of Radial Ultrasound probes
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.
Sponsors
Middlemore Hospital, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient referred for R-EBUS as per routine management. * Patient judged to be medically stable to give consent for this study.
Exclusion criteria
-Unsuitable for flexible bronchoscopy and biopsy * INR\>1.5 * Platelets\<150. * Hb\> 80g/l * Liver function tests (AST/ALT) \<2 times upper limit of normal * Neutrophil count \>1.0 * EGFR \>30ml/kg/min * On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing 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. | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suitability of the biopsy samples from each arm to perform EGFR mutation testing. | 18 months | 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. |
| Compare the procedure related bleeding and pneumothorax rates between the two arms. | 18 months | — |
Countries
New Zealand
Outcome results
None listed