Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.

Study Overview
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Brief Summary
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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)

Official Title
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Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick (1.7mm) With an Aspiration Needle Biopsy Vs. a Thin USS Probe (1.4mm), in Peripheral Lung Lesions.

Conditions
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Pulmonary Parenchymal Lesions

Intervention / Treatment
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* Procedure: Radial EBUS biopsy
* Device: Types of Radial Ultrasound probes


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thick USS (1.7mm) with use of additional aspiration needle<br> | Procedure: Radial EBUS biopsy<br>* Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.<br>Device: Types of Radial Ultrasound probes<br>* 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.<br>|
| Active Comparator: Thin USS (1.4mm)<br> | Procedure: Radial EBUS biopsy<br>* Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.<br>Device: Types of Radial Ultrasound probes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 biopsies give a diagnosis of malignancy and Will decide what is the best sample in comparing all samples from both arms defined as  the highest number of malignant cells/hpf. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 
| Compare the procedure related bleeding and pneumothorax rates between the two arms. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis