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Trial registered on ANZCTR


Registration number
ACTRN12617000390381p
Ethics application status
Submitted, not yet approved
Date submitted
14/03/2017
Date registered
16/03/2017
Date last updated
16/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual chromoendoscopy vs standard dye-based chromoendoscopy in Inflammatory Bowel Disease (IBD) surveillance.
Scientific title
Virtual chromoendoscopy using i-scan Optical Enhancement for detection and assessment of dysplasia in patients with Inflammatory Bowel Disease - A prospective tandem colonoscopy study.
Secondary ID [1] 291455 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 302493 0
Crohn's disease 302494 0
Inflammatory Bowel Disease 302505 0
Condition category
Condition code
Oral and Gastrointestinal 302051 302051 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual chromoendoscopy using Pentax i-scan Optical Enhancement
- this is an imaging system used during colonoscopy to assess the bowel where the endoscopist pushes a button on the colonoscope that enhances the image on the screen, highlighting abnormal features in the bowel lining that may otherwise be missed
- the intervention will be administered by an experienced Gastroenterologist
- the intervention will be administered during colonoscopy
- it will be performed on a single occasion
- the anticipated duration is 10-20 minutes
- both the test intervention and the control intervention will be performed during the same colonoscopy procedure
- it will be performed in a specialist endoscopy unit
Intervention code [1] 297505 0
Early detection / Screening
Intervention code [2] 297506 0
Diagnosis / Prognosis
Intervention code [3] 297507 0
Treatment: Devices
Comparator / control treatment
Dye-based chromoendoscopy
- this involves spraying the bowel wall with a dye during colonoscopy to help detect lesions
- this is the current "gold standard" intervention
- the intervention will be administered by an experienced Gastroenterologist
- the intervention will be administered during colonoscopy
- it will be performed on a single occasion
- the anticipated duration is 20-30 minutes
- both the test intervention and the control intervention will be performed during the same colonoscopy procedure
- it will be performed in a specialist endoscopy unit
Control group
Active

Outcomes
Primary outcome [1] 301472 0
Detection of colonic dysplasia
- % rate of dysplasia detection
- % rate of missed dysplastic lesions from virtual chromoendoscopy that were subsequently picked up on dye-based chromoendoscopy

These outcomes will be measured based on the histopathology reports of removed tissue
Timepoint [1] 301472 0
On day 0 (at the time of colonoscopy)
Secondary outcome [1] 332787 0
Mean procedure duration
- this will be measured in minutes
- it will look separately at time for colonoscope insertion and time for colonoscope withdrawal
Timepoint [1] 332787 0
On Day 0 (at time of colonoscopy)

Eligibility
Key inclusion criteria
Inflammatory bowel disease
- ulcerative colitis of duration greater than 8 years where there is disease extension beyond the splenic flexure
- Crohn's colitis of duration > 8 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children (age < 18)
Pregnant women
Those deemed medically unfit to safely undergo a colonoscopy

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2017
Actual
Date of last participant enrolment
Anticipated
13/04/2018
Actual
Date of last data collection
Anticipated
23/04/2018
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7679 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 7680 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 15597 0
4215 - Southport
Recruitment postcode(s) [2] 15598 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 295925 0
Hospital
Name [1] 295925 0
Gold Coast University Hospital
Country [1] 295925 0
Australia
Funding source category [2] 295926 0
Hospital
Name [2] 295926 0
Concord Repatriation General Hospital
Country [2] 295926 0
Australia
Primary sponsor type
Individual
Name
Dr Alexander Dorrington
Address
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 294797 0
Individual
Name [1] 294797 0
Dr Sneha John
Address [1] 294797 0
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country [1] 294797 0
Australia
Secondary sponsor category [2] 294798 0
Individual
Name [2] 294798 0
Professor Rupert Leong
Address [2] 294798 0
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country [2] 294798 0
Australia
Secondary sponsor category [3] 294799 0
Individual
Name [3] 294799 0
Dr John Edwards
Address [3] 294799 0
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country [3] 294799 0
Australia
Secondary sponsor category [4] 294800 0
Individual
Name [4] 294800 0
Dr Aravind Gokul Tamilarasan
Address [4] 294800 0
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country [4] 294800 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297203 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 297203 0
Ethics committee country [1] 297203 0
Australia
Date submitted for ethics approval [1] 297203 0
15/03/2017
Approval date [1] 297203 0
Ethics approval number [1] 297203 0

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

Contacts
Principal investigator
Name 73330 0
Dr Alexander Dorrington
Address 73330 0
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 73330 0
Australia
Phone 73330 0
+61756875616
Fax 73330 0
Email 73330 0
alexander.dorrington@health.qld.gov.au
Contact person for public queries
Name 73331 0
Alexander Dorrington
Address 73331 0
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 73331 0
Australia
Phone 73331 0
+61756875616
Fax 73331 0
Email 73331 0
alexander.dorrington@health.qld.gov.au
Contact person for scientific queries
Name 73332 0
Alexander Dorrington
Address 73332 0
Department of Gastroenterology
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 73332 0
Australia
Phone 73332 0
+61756875616
Fax 73332 0
Email 73332 0
alexander.dorrington@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.