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Trial registered on ANZCTR


Registration number
ACTRN12611000501943
Ethics application status
Approved
Date submitted
27/04/2011
Date registered
13/05/2011
Date last updated
13/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Pre-Procedure Virtual Bronchoscopy Planning Compared To Conventional Computed Tomographic Planning For Endobronchial Ultrasound Guide Sheath Procedures
Scientific title
In patients with peripheral pulmonary nodules who are undergoing EBUS GS directed biopsies, does pre-procedure planning with iLogic InReach virtual bronchoscopy software improve diagnostic yield and lesion localisation whilst also reducing procedure time and complication rate when compared to pre-procedure planning with conventional bi-axial CT scans?
Secondary ID [1] 259634 0
nil
Universal Trial Number (UTN)
U1111-1119-5277
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral pulmonary lesions 261202 0
Condition category
Condition code
Respiratory 259350 259350 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The iLogic inReach (superDimension) software creates a virtual bronchoscopic map as well as a three dimensional external map of the bronchial tree from information obtained from CT scan data. It also provides simultaneous review of CT scan images in three different planes (coronal, axial, sagittal). The bronchoscopist will use this software to map a pathway to the target lesion and will then review the intended pathway by virtual bronchoscopy. This planning method will take 5-30 minutes.

The EBUS GS system consists of a radial ultrasound probe which is inserted into a flexible guide sheath in the working channel of the bronchoscope. Ultrasound images help the bronchoscopist determine the density of the tissue which the radial probe is passing through. Normal lung produces a "snow storm" appearance whereas mass lesions show a well defined border which represents the change in density between normal aerated lung and the solid mass. The radial ultrasound probe is then removed and the pre-measured biopsy forceps and cytology brushes are then pass through the guide sheath to sample the target lesion.
Intervention code [1] 258068 0
Diagnosis / Prognosis
Intervention code [2] 264565 0
Treatment: Devices
Comparator / control treatment
Visual planning from biaxial CT scans is the conventional method for pre-procedure planning of EBUS GS procedures. The bronchoscopist uses the axial and sagittal views to map a pathway to the target lesion. This planning method takes between 1-5 minutes.

The EBUS GS system is explained above.
Control group
Active

Outcomes
Primary outcome [1] 262161 0
Diagnostic yield
Once the target lesion is localised using EBUS a minimum of 6 transbronchial biopsies, cytology brush samples and 5-10ml miniBAL will be taken for microbiology/culture/sensitivity, cytology and histology. Diagnostic yield will be calculated as :
number of procedures which provide a diagnosis / total number of procedures.

In cases where EBUS GS directed biopsies does not provide a diagnosis, the patient will be followed up for 12 months to determine whether other subsequent diagnostic modalities provide a histological diagnosis.
Timepoint [1] 262161 0
12 months after procedure
Primary outcome [2] 262162 0
Complication rate (pneumothorax, unplanned hospital admission, major and minor bleeding)
Timepoint [2] 262162 0
Upto one week after procedure
Primary outcome [3] 262163 0
Procedure Time
Timepoint [3] 262163 0
Time of procedure
Secondary outcome [1] 273249 0
Localisation of lesion on EBUS GS
Timepoint [1] 273249 0
At time of procedure

Eligibility
Key inclusion criteria
Age 18-85
Patients with a peripheral pulmonary nodule undergoing EBUS GS directed biopsy for diagnosis
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Inability to provide consent

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)
Participants will be enrolled when EBUS GS bronchoscopy booking is made.

Allocation is concealed and will be performed centrally by computer generated random numbers.

This will not be a blinded study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258530 0
Government body
Name [1] 258530 0
Queensland Policy and Advisory Committee for New Technology
Country [1] 258530 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Queensland Health Building
147-163 Charlotte St
Brisbane
Queensland
4000
Country
Australia
Secondary sponsor category [1] 264056 0
Hospital
Name [1] 264056 0
The Prince Charles Hospital
Address [1] 264056 0
Rode Rd
Chermside
Brisbane
Queensland
4032
Country [1] 264056 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260500 0
Research, Ethics and Governance Unit, The Prince Charles Hospital
Ethics committee address [1] 260500 0
Ethics committee country [1] 260500 0
Australia
Date submitted for ethics approval [1] 260500 0
24/02/2011
Approval date [1] 260500 0
30/03/2011
Ethics approval number [1] 260500 0
HREC/11/QPCH/37

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

Contacts
Principal investigator
Name 32237 0
Address 32237 0
Country 32237 0
Phone 32237 0
Fax 32237 0
Email 32237 0
Contact person for public queries
Name 15484 0
Dr Steven Leong
Address 15484 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Rd
Chermside
Brisbane
Queensland
4032
Country 15484 0
Australia
Phone 15484 0
+61 7 3139 4000
Fax 15484 0
Email 15484 0
steven_leong@health.qld.gov.au
Contact person for scientific queries
Name 6412 0
Dr Steven Leong
Address 6412 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Rd
Chermside
Brisbane
Queensland
4032
Country 6412 0
Australia
Phone 6412 0
+61 7 3139 4000
Fax 6412 0
Email 6412 0
steven_leong@health.qld.gov.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.