Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000395437p
Ethics application status
Submitted, not yet approved
Date submitted
15/03/2016
Date registered
29/03/2016
Date last updated
6/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Olympus 190 series narrow band imaging for colonic polyp detection rates: A prospective randomised multicentre study
Scientific title
Assessing the Olympus 190 series narrow band imaging for colonic polyp detection rates in patients undergoing diagnostic colonoscopy: A prospective randomised multicentre study
Secondary ID [1] 288763 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal polyps/cancer 298011 0
Condition category
Condition code
Oral and Gastrointestinal 298171 298171 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 298227 298227 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are selected from patients already undergoing colonoscopy for various indications (Ie; family history of colorectal cancer, signs or symptoms concerning for bowel disease). The only intervention study participants are exposed to is a colonoscopy that they would undergo regardless of their involvement in the study.

Patients undergo colonoscopy and are randomised prior to the procedure to either narrow band imaging or standard white light on Olympus 190 series colonoscopes. These are illumination settings on the colonoscope and can be used by a simple push of a button. Narrow band imaging uses filters to illuminate tissue at a selected wavelengths (415 and 540nm)- giving a high definition and excellent visual determination of polyp/adenoma histology. The proceduralist will be told prior to the procedure which modality they will be required to use and then they will complete the withdrawal of the colonoscope (when polyp detection is predominantly done) in this modality.

The procedure will be performed by consultant gastroenterologists or advanced trainees under the direct supervision of consultants. Each procedure usually takes about 15 minutes and they will all be required to have a withdrawal time of at least 7 minutes (which is associated with a higher polyp and adenoma pick up rate).
Intervention code [1] 294202 0
Early detection / Screening
Intervention code [2] 294203 0
Diagnosis / Prognosis
Comparator / control treatment
Both groups undergo colonoscopy.
Trial group undergoes colonoscopy with withdrawal in narrow band imaging mode of illumination.
Control group undergoes colonoscopy with withdrawal in standard white light mode of illumination.

Standard white light is the default illumination setting of the colonoscope and uses no filters to limit the light's wavelength. Patient's randomised to have their colonoscopy in standard white light will have a standard colonoscopy with a withdrawal time of at least 7 minutes.
Control group
Active

Outcomes
Primary outcome [1] 297681 0
adenoma detection rate- proportion of screening colonoscopies that detect 1 or more adenomas. This is will be done by reviewing colonoscopy reports and histology reports for all patients involved in the study.
Timepoint [1] 297681 0
after colonoscopy randomised to narrow band imaging or standard white light
Secondary outcome [1] 321813 0
polyp detection rate- by review of histology and colonoscopy reports.
Timepoint [1] 321813 0
after colonoscopy randomised to narrow band imaging or standard white light
Secondary outcome [2] 322026 0
size of polyps detected by reviewing colonoscopy reports
Timepoint [2] 322026 0
after colonoscopy randomised to narrow band imaging or standard white light
Secondary outcome [3] 322027 0
location of polyps detected by review of colonoscopy reports
Timepoint [3] 322027 0
after colonoscopy randomised to narrow band imaging or standard white light
Secondary outcome [4] 322028 0
histology of polyps detected by reviewing histology/pathology reports. We plan to look at histology (ie: adenoma, hyperplastic polyp, adenocarcinoma, tubulovillous adenoma) and whether there are any features of dysplasia etc.
Timepoint [4] 322028 0
after colonoscopy randomised to narrow band imaging or standard white light
Secondary outcome [5] 322029 0
quality of bowel preparation as per the Harefield bowel cleansing scale (each segment of bowel will be assessed individually and then a composite total score for the entire cleanliness of the bowel will be given).
Timepoint [5] 322029 0
after colonoscopy randomised to narrow band imaging or standard white light

Eligibility
Key inclusion criteria
- Age above 18 years.
- Able to give informed consent.
- Scheduled to undergo colonoscopy for various indications (family history of colorectal cancer, faecal occult blood test positive, altered bowel habit, rectal bleeding etc).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to complete colonoscopy
- Age below 18 years.
- Active upper gastrointestinal haemorrhage.
- Active anti-coagulation (aspirin is okay).
- Any contraindication to undergo routine colonoscopy and be sedated.

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)
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
1/05/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 293126 0
Self funded/Unfunded
Name [1] 293126 0
Self funded/unfunded
Country [1] 293126 0
Primary sponsor type
Hospital
Name
Gastroenterology Department RPAH
Address
RPAH
Missenden Road
Camperdown, NSW
2042
Country
Australia
Secondary sponsor category [1] 291921 0
None
Name [1] 291921 0
none
Address [1] 291921 0
none
Country [1] 291921 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294621 0
RPA zone ethics committee of SLHD
Ethics committee address [1] 294621 0
Ethics committee country [1] 294621 0
Australia
Date submitted for ethics approval [1] 294621 0
04/04/2016
Approval date [1] 294621 0
Ethics approval number [1] 294621 0

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy of the Olympus 190 series colonoscope narrow band imaging (NBI) technology for the detection of polyps and adenomas, in comparison to the current standard white light technology used during colonoscopies. Research to date has found no difference between the two technologies of illumination, but with improved technology we believe that NBI may now improve our detection rate of polyps and adenomas- thereby decreasing the overall cancer risk per patient.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over, and have been scheduled to undergo a colonoscopy for diagnostic/investigational purposes.

Study details
All participants in this study will be randomly allocated (by chance) to receive either the NBI or standard white light colonoscopy. All other aspects of the procedure, other than the type of light used during the colonoscope withdrawal will remain the same between each group, as per standard care. NBI is simply a type of light available by pushing a button on the colonoscope, which uses filters to illuminate tissue at a selected wavelength. This may be beneficial for the detection of polyps and adenomas, despite providing less illumination overall than the standard white light.

Researchers will then review the colonoscopy procedure and histological notes to assess the detection rates for polyps and adenomas between each type of light. Subsequently, statistical analysis will determine which technology is better for polyp and adenoma detection.

It is hoped that the findings of this trial will provide information on which type of light may be the most effective for the detection of polyps and adenomas in patients undergoing colonoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64390 0
Dr Arthur Kaffes
Address 64390 0
Suite G 10, RPAH Medical centre
100 Carillion Ave
Camperdown, NSW
2042
Country 64390 0
Australia
Phone 64390 0
+61 2 95162033
Fax 64390 0
Email 64390 0
[email protected]
Contact person for public queries
Name 64391 0
Dr Aravind Gokul Tamilarasan
Address 64391 0
AW Morrow Gastroenterology unit
Level 9, Royal Prince Alfred Hospital
Missenden Rd
Camperdown, NSW
2042
Country 64391 0
Australia
Phone 64391 0
+61 2 95150056
Fax 64391 0
Email 64391 0
[email protected]
Contact person for scientific queries
Name 64392 0
Dr Aravind Gokul Tamilarasan
Address 64392 0
AW Morrow Gastroenterology unit
Level 9, Royal Prince Alfred Hospital
Missenden Rd
Camperdown, NSW
2042
Country 64392 0
Australia
Phone 64392 0
+61 2 95150056
Fax 64392 0
Email 64392 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.