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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02739126
Registration number
NCT02739126
Ethics application status
Date submitted
19/02/2016
Date registered
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.
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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.
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Secondary ID [1]
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R- EBUST 2
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Universal Trial Number (UTN)
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Trial acronym
R-EBUST2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Parenchymal Lesions
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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".
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
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Assessment method [1]
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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".
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Compare the procedure related bleeding and pneumothorax rates between the two arms.
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Assessment method [2]
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Timepoint [2]
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18 months
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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.
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2017
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Actual
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Sample size
Target
88
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Middlemore Hospital, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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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)
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Trial website
https://clinicaltrials.gov/study/NCT02739126
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02739126