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

Not Applicable

• Conditions: Pulmonary Parenchymal Lesions
• Interventions: Procedure: Radial EBUS biopsy; Device: Types of Radial Ultrasound probes

• Registration Number: NCT02739126
• Lead Sponsor: Middlemore Hospital, New Zealand

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-02-19
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-10
• Last Update Submitted: 2016-04-10
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thick USS (1.7mm) with use of additional aspiration needle	Types of Radial Ultrasound probes	-
Thin USS (1.4mm)	Radial EBUS biopsy	-
Thick USS (1.7mm) with use of additional aspiration needle	Radial EBUS biopsy	-
Thin USS (1.4mm)	Types of Radial Ultrasound probes	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Middlemore Hospital, Counties Manakau District Health Board; 🇳🇿 Auckland, New Zealand