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Trial registered on ANZCTR


Registration number
ACTRN12619000703101
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
10/05/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial of peripheral lung lesion evaluation with radial probe endobronchial ultrasound via an ultraslim bronchoscope and sampling method including a flexible needle
Scientific title
Clinical trial of peripheral lung lesion evaluation with radial probe endobronchial ultrasound via an ultraslim bronchoscope and diagnostic yield with sampling method including a flexible needle
Secondary ID [1] 297886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral pulmonary lesion (PPL) 312260 0
Lung cancer 312261 0
Condition category
Condition code
Respiratory 310807 310807 0 0
Other respiratory disorders / diseases
Cancer 310863 310863 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bronchoscopy (to be performed by respiratory physician or supervised advanced trainee) using Olympus MP-190F ultraslim bronchoscope with radial probe endobronchial ultrasound (rEBUS). Upon identification of adequate ultrasound image (concentric or eccentric), sampling using standard methods (forcep biopsy and brush) plus transbronchial needle aspiration (TBNA) using Olympus PeriView Flex needle. Order of sampling will be randomised 1:1 (TBNA before or after standard methods).
2 stage trial performed on a participant in a single one hour procedure.
Stage 1 - identification of lesion based on ultrasound image
Stage 2 - sampling of lesion if identified by ultrasound
Intervention code [1] 314115 0
Diagnosis / Prognosis
Comparator / control treatment
1. In patients where no adequate ultrasound image obtained, endobronchial ultrasound with guide sheath (EBUS GS) procedure to be undertaken, ultrasound image obtained via guide sheath as comparator.
2. Standard of care procedure (forcep biopsy and brush).
Sampling order randomisation to reduce order bias of sampling method.
Control group
Active

Outcomes
Primary outcome [1] 319651 0
Proportion of procedures demonstrating adequate ultrasound target (concentric or eccentric). Concentric defined as circumferential or greater than 180 degree ultrasound abnormality. Eccentric defined as less than 180 degree ultrasound abnormality.
Timepoint [1] 319651 0
At time of procedure.
Primary outcome [2] 319652 0
Incremental diagnostic yield of flexible TBNA vs standard of care. Diagnostic yield defined as proportion of cases with definitive diagnosis made on basis of bronchoscopic sampling.
Timepoint [2] 319652 0
At time of procedure and followup of non-malignant biopsy results at 6-12 months.
Secondary outcome [1] 369017 0
Endobronchial disease only recognised by ultraslim bronchoscope (not seen with standard bronchoscopy procedure)
Timepoint [1] 369017 0
At time of procedure
Secondary outcome [2] 369018 0
Type of ultrasound image obtained (concentric vs eccentric)
Timepoint [2] 369018 0
At time of procedure
Secondary outcome [3] 369019 0
Time for procedure. Timer commenced upon first crossing vocal cords, 'split' when ultraslim bronchoscope crossing cords (if alternative bronchoscope used first), 'split' with rEBUS probe, stop on bronchoscope removal.
Timepoint [3] 369019 0
At time of procedure
Secondary outcome [4] 369020 0
Cost of consumables used, based upon costing of individual components (eg guide sheath kit, needles, additional forceps). This will not include cost of staff/theatre time. To be estimated by respiratory physician.
Timepoint [4] 369020 0
At time of procedure
Secondary outcome [5] 369021 0
Adverse events (moderate bleeding/pneumothorax/unplanned hospital admission/death).
Moderate bleeding defined as requiring intervention (eg cold saline/adrenaline/balloon blocker etc).
Pneumothorax defined as clearly visible visceral pleural edge without distal lung markings seen on post procedure screening xray or xray upon subsequent presentation.
Timepoint [5] 369021 0
1 week post procedure

Eligibility
Key inclusion criteria
• Consecutive cases proposed for EBUS GS biopsy of PPL requiring tissue diagnosis at The Prince Charles Hospital
• Adult patients >18 years old
• Capable of providing written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unacceptably high risk for anaesthetic, bronchoscopy or bleeding
• Pregnancy
• High risk of pneumothorax with needle sampling eg bullous change surrounding lesion
• Biopsy forcep size >1.5mm required

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Stage 1: This is a pilot study as a total sample size of 298 with 149 in each group would achieve 80% power to detect a non-inferiority margin difference between the group proportions of -0.10. The reference group proportion is 0.86. The intervention group proportion is assumed to be 0.76 under the null hypothesis of inferiority. The power was computed for the case when the actual treatment group proportion is 0.86. The test statistic used is the one-sided Z test (pooled). The significance level of the test was targeted at 0.05

Stage 2: A superiority study with hypothesis increase diagnostic yield from 48% (recent institutional audit) to 73% (recent multi centre RCT) with a sample size of 50 (all patients receiving both tests) achieves 81% power to detect an odds ratio of 9.0 using a two-sided McNemar test with a significance level of 0.05. This is equivalent to a difference between two paired proportions of 0.20 when the proportion of discordant pairs is 0.25.

The overall planned sample size (100) is greater than that required to demonstrate superiority in stage 2 in order to provide further data for pilot study stage 1.

These calculations performed using PASS software package (version 13).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2019
Actual
13/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
56
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13550 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 26173 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 302409 0
Hospital
Name [1] 302409 0
The Prince Charles Hospital
Country [1] 302409 0
Australia
Primary sponsor type
Individual
Name
Dr Gerard Olive
Address
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 302303 0
None
Name [1] 302303 0
None
Address [1] 302303 0
None
Country [1] 302303 0
Other collaborator category [1] 280629 0
Commercial sector/Industry
Name [1] 280629 0
Olympus Australia
Address [1] 280629 0
3 Acacia Place
Notting Hill
Victoria 3168
Country [1] 280629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303078 0
The Prince Charles Hospital HREC
Ethics committee address [1] 303078 0
Ethics committee country [1] 303078 0
Australia
Date submitted for ethics approval [1] 303078 0
03/04/2019
Approval date [1] 303078 0
05/08/2019
Ethics approval number [1] 303078 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92390 0
Dr Gerard Olive
Address 92390 0
The Prince Charles Hospital
Rode Road
Chermside QLD
4032
Country 92390 0
Australia
Phone 92390 0
+61 7 3139 4000
Fax 92390 0
Email 92390 0
[email protected]
Contact person for public queries
Name 92391 0
Gerard Olive
Address 92391 0
The Prince Charles Hospital
Rode Road
Chermside QLD
4032
Country 92391 0
Australia
Phone 92391 0
+61 7 3139 4000
Fax 92391 0
Email 92391 0
[email protected]
Contact person for scientific queries
Name 92392 0
Gerard Olive
Address 92392 0
The Prince Charles Hospital
Rode Road
Chermside QLD
4032
Country 92392 0
Australia
Phone 92392 0
+61 7 3139 4000
Fax 92392 0
Email 92392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.