Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02739126




Registration number
NCT02739126
Ethics application status
Date submitted
19/02/2016
Date registered
15/04/2016
Date last updated
15/04/2016

Titles & IDs
Public title
Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.
Scientific title
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.
Secondary ID [1] 0 0
R- EBUST 2
Universal Trial Number (UTN)
Trial acronym
R-EBUST2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Parenchymal Lesions 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Radial EBUS biopsy
Treatment: Devices - Types of Radial Ultrasound probes

Active Comparator: Thick USS (1.7mm) with use of additional aspiration needle -

Active Comparator: Thin USS (1.4mm) -


Treatment: Surgery: Radial EBUS biopsy
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Compare the procedure related bleeding and pneumothorax rates between the two arms.
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
- Patient referred for R-EBUS as per routine management.

- Patient judged to be medically stable to give consent for this study.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Middlemore Hospital, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02739126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02739126