Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe. (R-EBUST2)

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.

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 Overview

• Status: Unknown
• Conditions: Pulmonary Parenchymal Lesions
• Intervention / Treatment: Procedure: Radial EBUS biopsy; Device: Types of Radial Ultrasound probes

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2025
    • Recruiting
    • Middlemore Hospital, Counties Manakau District Health Board
    • Contact: Samantha Herath; Phone Number: +64211298979; Email: scherath@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Middlemore Hospital, New Zealand

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: April 10, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 10, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Diagnosis
• Other Study ID Numbers: R- EBUST 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No