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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
Gold Coast University Hospital
1 Hospital Blvd Southport
QLD 4215
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
Dysplasia is an important precursor to bowel cancer in IBD, which can be very challenging to detect. Previous studies suggest that dysplasia is detected in approximately 9% of colonoscopies performed for IBD surveillance.

Dye-based chromoendoscopy (DBC) which involves spraying the entire colon with contrast materia such as indigo carmine or methylene blue is thought of as the current gold standard for dysplasia detection. However, dye-based chromoendoscopy is expensive, time consuming and difficult to perform, which limits its use as a surveillance test. A routine survey of Australian Gastroenetrologists suggests that more than half did not use the dye-spray technique.

Virtual chromoendoscopy with Pentax i-scan Optical Enhancement(OE) uses in-built technology in the endoscope processor with the same principles as dye-based chromoendoscopy to enhance colonic mucosal pit and vessel pattern. We therefore hypothesise that virtual chromoendoscopy is non-inferior to dye spray chromoendoscopy in detecting dysplasia. It will also consume less resources and time. The aim of our study is to compare virtual and dye-based chromoendoscopy in a prospective tandem colonoscopy study.

Research design & methods:

We plan to conduct a prospective study, enrolling patients with known IBD who are due to have their standard surveillance colonoscopy to look for dysplasia. A tandem colonoscopy model will be used. Enrolled participants will have a colonoscopy using virtual chromoendoscopy with i-scan OE first during insertion and withdrawal. All lesions detected will be removed or biopsied, as appropriate. On completion of withdrawal, a second look will be performed with dye-spraying as is the current clinical practice. This will allow any additional pathology detected to be treated.
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
[email protected]
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
[email protected]
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
[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

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No documents have been uploaded by study researchers.

Documents added automatically
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