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Trial registered on ANZCTR


Registration number
ACTRN12621001736831
Ethics application status
Approved
Date submitted
9/09/2021
Date registered
20/12/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
20/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acquire versus ViziShot needles in Endobronchial Ultrasound Guided Lymph Node Aspiration
Scientific title
Prospective randomised evaluation of the proportion of diagnostic samples collected by Acquire versus ViziShot needles during Endobronchial Ultrasound Guided Lymph Node Aspiration
Secondary ID [1] 305278 0
None
Universal Trial Number (UTN)
Trial acronym
ACQUI-SHOT Trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mediastinal lymphadenopathy
 323577 0
lung cancer 323578 0
Condition category
Condition code
Respiratory 321124 321124 0 0
Other respiratory disorders / diseases
Cancer 321125 321125 0 0
Lung - Non small cell
Cancer 321126 321126 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure: patients whose mediastinal lymph node sample was taken using Acquire Needle (manufacturer: Boston Scientific).

All patients who are referred to mediastinal/hilar lymph node sampling will be screened. Sampling is done by interventional pulmonologists and there are 2 needs available to taking samples.

We denoted Acquire needle (Boston Scientific) as "interventional" as it is newer but technically we are not intervening but rather comparing 2 methods of obtaining samples. Acquire needles have 3 cut points and pierces lymph nodes easier.

The procedure usually takes 45 min (including anaesthesia, examining bronchi then examining lymph nodes and taking samples). All procedures are done by an interventional pulmonologist or a trainee under direct supervision.
Intervention code [1] 321682 0
Treatment: Devices
Intervention code [2] 321683 0
Diagnosis / Prognosis
Comparator / control treatment
Control: patients whose mediastinal lymph node sample was taken using ViziShot Needle (manufacturer: Olympus)

ViziShot needles are similar to conventional needles used for withdrawing bloods. Its tip is different of Acquire and hence it is being compared to see if one needle is superior. We denoted ViziShot as "Control" as it has been used for longer period in interventional pulmonology field. However, it is a comparative study rather than "interventional" where all participants receive the same treatment except for the intervention. In this study, we are only randomising which needle used to take biopsy rather than "intervening" with any process.

All procedures are done by an interventional pulmonologist or a trainee under direct supervision.
Control group
Active

Outcomes
Primary outcome [1] 328902 0
Proportion of diagnostic samples per needle of out all needle aspirations. Samples will be transferred to slides that are examined by on site cytologist and will be denoted as "sufficient material" or non-sufficient (ie bloods)
Timepoint [1] 328902 0
Immediately post-aspiration procedure.
Primary outcome [2] 328903 0
Complications related to lymph node aspiration (pneumothorax or haemoptysis or infection or unexpected visit to ED)
Timepoint [2] 328903 0
Participants will be phoned between 7-10 days post-aspiration procedure to check these outcomes.
Primary outcome [3] 328904 0
Proportions of needle failure (ie how often interventional pulmonologist has to change needle used take biopsy). This will be written by the proceduralist on study specific form immediately post procedure.
Timepoint [3] 328904 0
Evaluated immediately during procedure and to be written on study specific form.
Secondary outcome [1] 400832 0
Proportions of participants who needed repeat procedure. This will be collected by checking medical records that participants had or did not have a repeat procedure.
Timepoint [1] 400832 0
Evaluated 6 weeks after aspiration procedure.
Secondary outcome [2] 400833 0
Time taken to perform procedure using each needle determined by digital watch.
Timepoint [2] 400833 0
Immediately post-aspiration procedure.

Eligibility
Key inclusion criteria
All patients referred to Transbronchial Node Aspiration (TBNA) by Endoscopic Ultrasound (EBUS) that meet the following criteria:
- Adults (defined as older than or equal to 18 years of age). There is no upper limit of age provided participants can consent.
- Outpatient/Elective admission to perform the procedure
- Not on anticoagulation (or withheld prior to procedure). Aspirin is ok
- Able to consent
- First TBNA (linear) EBUS (not a redo procedure and no linear EBUS with last 8 weeks).
- Repeat EBUS due to participants intolerance is considered to be failure of bronchoscopy/sedation rather than failure of biopsy needle. The failed procedure results will be not be counted
- At least 1 lymph node size greater or equal to 10 mm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to consent, this includes but not limited to participants with dementia, intellectual difficulties, or inability to communicate.
- Contraindication to taking biopsy – ie on anticoagulation or dual antiplatelets therapy within 48 hrs of procedure or INR > 1.5
- Inpatients (due to being sick, likely less time to consider participation and making an informed consent). To clarify, inpatients refer to patients who were admitted via emergency department and does not include elective admission to facilitate a procedure or investigations such as who live far away from Lyell McEwin Hospital.

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)
Centralised randomisation via Redcap software (once a patient is enrolled, Redcap randomises this patient to either Acquire needle or ViziShot needle).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation table was created using permuted block randomisation. R software is used to generate random sequence. Randomisation is stratified by first targeted biopsy site (hilar versus mediastinal location)
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
We anticipate that Acquire needle has 87% successful first pass while ViziShot has 64% successful pass rate. Based on these estimates, a sample size of 108 (54 in each group) provides a power of 80% to detect this difference.

Data analysis will be performed using R statistics. Using mixed logistic model, we aim to calculate the odds of a diagnostic pass after adjusting for location and number of lymph node(s) targeted for sampling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/08/2021
Date of last participant enrolment
Anticipated
2/02/2022
Actual
Date of last data collection
Anticipated
9/03/2022
Actual
Sample size
Target
108
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20504 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 35281 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 309651 0
Self funded/Unfunded
Name [1] 309651 0
Not funded
Country [1] 309651 0
Primary sponsor type
Individual
Name
Dr Moayed Alawami
Address
Respiratory Department
Lyell McEwin Hospital
Haydown st
Elizabeth Vale, South Australia 5112
Country
Australia
Secondary sponsor category [1] 310667 0
None
Name [1] 310667 0
Address [1] 310667 0
Country [1] 310667 0
Other collaborator category [1] 281980 0
Individual
Name [1] 281980 0
Dr Thanuja Singankutti Mudalige
Address [1] 281980 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, South Australia 5112
Country [1] 281980 0
Australia
Other collaborator category [2] 281981 0
Individual
Name [2] 281981 0
Dr Shanka Karunarathne
Address [2] 281981 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country [2] 281981 0
Australia
Other collaborator category [3] 281982 0
Individual
Name [3] 281982 0
Ms Taylar Tallboy
Address [3] 281982 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country [3] 281982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309419 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309419 0
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 309419 0
Australia
Date submitted for ethics approval [1] 309419 0
Approval date [1] 309419 0
13/08/2021
Ethics approval number [1] 309419 0
OFR Number: 142.21; HREC reference number: LNR/21/SAC/142

Summary
Brief summary
This study is aiming to determine whether one of two needles (that are approved by the Therapeutics and Goods Administration) is better than the other for taking samples from mediastinal (chest) lymph nodes for the diagnosis of lung cancers.

Who is it for?
You may be eligible for this study if you are aged 18 or older and you have been referred by your doctor to undergo a chest lymph node biopsy procedure known as Transbronchial Node Aspiration by Endoscopic Ultrasound. Participants may have a known cancer diagnosis or will be undergoing this procedure to determine a final diagnosis such as, but not limited to, lung cancer, sarcoidosis or tuberculosis.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin), to undergo a biopsy by one needle (Acquire), or the other (ViziShot). The biopsy procedure will involve giving anaesthetics then examining airways using a camera passed via vocal cords. Both procedures will be the same, the only difference will be which needle is used. 7- 10 days after the procedure, a member of the research team will phone all participants to check if they have experienced any side effects potentially related to the procedure, including going to the emergency department.

It is hoped this research will determine whether one needle is superior to the other, and this may then improve current practice by reducing the number of biopsies needed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114094 0
Dr Moayed Alawami
Address 114094 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 114094 0
Australia
Phone 114094 0
+61422760802
Fax 114094 0
+61881829355
Email 114094 0
moayed.alawami@sa.gov.au
Contact person for public queries
Name 114095 0
Dr Moayed Alawami
Address 114095 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 114095 0
Australia
Phone 114095 0
+61422760802
Fax 114095 0
+61881829355
Email 114095 0
moayed.alawami@sa.gov.au
Contact person for scientific queries
Name 114096 0
Dr Moayed Alawami
Address 114096 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 114096 0
Australia
Phone 114096 0
+61422760802
Fax 114096 0
+61881829355
Email 114096 0
moayed.alawami@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13152Study protocol    382759-(Uploaded-09-09-2021-18-27-28)-Study-related document.docx
13154Ethical approval    382759-(Uploaded-09-09-2021-18-28-33)-Study-related document.pdf
13155Informed consent form    382759-(Uploaded-09-09-2021-18-29-22)-Study-related document.pdf



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.