ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal polyps/cancer

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Cancer

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]

Early detection / Screening

Intervention code [2]

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]

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]