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Trial registered on ANZCTR


Registration number
ACTRN12618000790246
Ethics application status
Approved
Date submitted
30/04/2018
Date registered
10/05/2018
Date last updated
6/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing the diagnostic yield of initial forceps biopsy vs brushings in Radial Guide Sheath Endobronchial Ultrasound lung biopsy
Scientific title
Randomised controlled trial comparing the diagnostic yield of initial forceps biopsy vs brushings in Radial Guide Sheath Endobronchial Ultrasound lung biopsy
Secondary ID [1] 294752 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 307647 0
Condition category
Condition code
Cancer 306714 306714 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The radial guide sheath endobronchial ultrasound guided lung biopsies will be performed as per the usual practice at Sunshine Coast University Hospital utilising the usual equipment used for the procedure (Olympus BF190 or Olympus BF3C20 bronchoscope).
- All procedures will be performed in the endoscopy unit at Sunshine Coast University. The bronchoscopist (respiratory physician or advanced trainee) will review the most recent CT Chest scan of the patient and determine the sub-segmental anatomical location of the lesions to be sampled.
- Bronchoscopy will be performed under a general anaesthetic with the bronchoscope passed through a laryngeal mask airway and less commonly through an endotracheal tube, at the discretion of the anaesthetist.
- The airways will be examined to segmental and sub-segmental level bilaterally.
- Once the bronchoscope is in predetermined sub-segmental airway and cannot be advanced any further, the radial EBUS probe covered with the guide sheath is advanced though the working channel of the bronchoscope towards the lesion. The radial EBUS provides a high resolution 360 degree view of the surrounding lung. The usual characteristic ultrasound features of normal and abnormal lung tissue will be used to identify the lesion. Once the lesion is located, the radial EBUS probe is withdrawn while the guide sheath is left in place as an extended working channel. The sampling instruments (biopsy forceps and brush) are then advanced through the guide sheath to the lesion to obtain tissue samples.

The sampling sequence will be randomly allocated prior to the procedure. The study arms are:
A1) 6 forceps biopsies and 2 brushings
A2) 3 forceps biopsies and 2 brushings and 3 forceps biopsies
B) 2 brushings and 6 forceps biopsies.

- All the collected specimens will be labelled and sent to the Sunshine Coast University Hospital laboratory for processing as per usual practice. The laboratory staff will receive the standard specimen jars:
o All forceps biopsy specimens in a formalin jar
o Brushings smeared on slides and the brush tip in a formalin jar
o Washings in a specimen jar.

- The usual procedure time is 30 minutes.
Intervention code [1] 301051 0
Treatment: Devices
Intervention code [2] 301074 0
Diagnosis / Prognosis
Comparator / control treatment
The participants will be randomized into different sequence of sampling during the same procedure. The initial sampling method and sequence of sampling will vary according to the study arms. All patients will have the same number and type of sampling method by the end of the procedure.
Control group
Active

Outcomes
Primary outcome [1] 305716 0
Percentage of procedures in each arm which resulted in obtaining a histological diagnosis from the samples taken (ie: a positive test). The final pathology report on the samples taken will be used to assess this outcome.
Timepoint [1] 305716 0
At the time of procedure.
Secondary outcome [1] 346231 0
1. Sufficient tissue to perform molecular testing if malignancy confirmed. The final pathology report on the samples taken will be used to assess this outcome. This outcome is a dichotomous outcome (ie: sufficient tissue for molecular testing present? yes/no)
Timepoint [1] 346231 0
At the time of procedure.
Secondary outcome [2] 346490 0
2. Impact of the ultrasound image on the diagnostic yield: sub-group analysis of >180 degree view of the lesion on ultrasound vs <180 degree view of the lesion on ultrasound. The final pathology report on the samples taken will be used to assess this outcome.
Timepoint [2] 346490 0
At the time of procedure
Secondary outcome [3] 346491 0
3. Impact of the location of the lesion (lobar anatomy of the lung) on the diagnostic yield. The final pathology report on the samples taken will be used to assess this outcome.
Timepoint [3] 346491 0
At the time of procedure
Secondary outcome [4] 346554 0
4. Rate of complications of the procedure. The known potential complications include: pneumothorax, bleeding and infection. Each patient will undergo a chest X-ray to assess for a pneumothorax after the procedure as per the usual practice. The amount of bleeding is assessed during the procedure. Procedure related infections will be defined as symptoms of chest infection requiring antibiotics within one week of the procedure.
Timepoint [4] 346554 0
Pneumothorax and bleeding - at the time of procedure
Infection - within one week of the procedure as assessed at the first routine clinic follow-up following the procedure.
Secondary outcome [5] 346555 0
5. Procedural time as measured using the stopwatch in the endoscopy suite.
Timepoint [5] 346555 0
At the end of the procedure.

Eligibility
Key inclusion criteria
All patients booked and consented for a radial guide sheath EBUS at Sunshine Coast University Hospital by the treating respiratory physician will be eligible to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Radial guide sheath EBUS of the same lesion within 2 weeks prior to enrolment.
- Lesion size <1.5cm in the long axis on the most recent CT scan prior to the procedure.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants receive all the interventions, but the sequence of the intervention will be different in each study arm.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: 56 patients will be enrolled in the study to detect a 20% difference in the diagnostic yield in the two arms with a power 80% (5% significance) and no lost to follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2018
Actual
4/06/2018
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
8/05/2019
Actual
Sample size
Target
56
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10822 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 22562 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 299359 0
Hospital
Name [1] 299359 0
Sunshine Coast University Hospital
Country [1] 299359 0
Australia
Primary sponsor type
Individual
Name
Dr Chinthaka Samaranayake
Address
Department of Respiratory Medicine
Sunshine Coast University Hospital
6 Doherty St
Birtinya QLD 4575
Country
Australia
Secondary sponsor category [1] 298634 0
None
Name [1] 298634 0
Address [1] 298634 0
Country [1] 298634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300264 0
Royal Brisbane and Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 300264 0
Ethics committee country [1] 300264 0
Australia
Date submitted for ethics approval [1] 300264 0
10/04/2018
Approval date [1] 300264 0
04/06/2018
Ethics approval number [1] 300264 0
HREC/18/QRBW/236

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

Contacts
Principal investigator
Name 83090 0
Dr Chinthaka Bhagya Samaranayake
Address 83090 0
Department of Respiratory Medicine
Sunshine Coast University Hospital
PO BOX 5340, Sunshine Coast MC Q4560
Country 83090 0
Australia
Phone 83090 0
+61752020000
Fax 83090 0
Email 83090 0
[email protected]
Contact person for public queries
Name 83091 0
Chinthaka Bhagya Samaranayake
Address 83091 0
Department of Respiratory Medicine
Sunshine Coast University Hospital
PO BOX 5340, Sunshine Coast MC Q4560
Country 83091 0
Australia
Phone 83091 0
+61752020000
Fax 83091 0
Email 83091 0
[email protected]
Contact person for scientific queries
Name 83092 0
Chinthaka Bhagya Samaranayake
Address 83092 0
Department of Respiratory Medicine
Sunshine Coast University Hospital
PO BOX 5340, Sunshine Coast MC Q4560
Country 83092 0
Australia
Phone 83092 0
+61752020000
Fax 83092 0
Email 83092 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Samaranayake CB, Wright C, Erigadoo S, Azzopardi M... [More Details]

Documents added automatically
No additional documents have been identified.