Clinical Evaluation of Narrow Band Imaging Colonoscope

Study Overview
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Brief Summary
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The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

Detailed Description
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This is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. Though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. Research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. Advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. A new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). Initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. As such, we hypothesized that the use of NBI would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. We aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Official Title
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Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Device: Narrow band imaging colonoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred for elective outpatient colonoscopy Exclusion Criteria: known inflammatory bowel disease personal or family history of polyposis syndrome referral for resection of a known lesion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrow band imaging colonoscope<br>narrow band imaging colonoscope | Device: Narrow band imaging colonoscope<br>* Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.<br>* Other names: Evis Exera II CV-180;|
| No Intervention: White Light<br>Conventional White Light Examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neoplasm Miss Rate |  | same day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neoplasm Detection Rates |  | same day | 
| Completion of Examinations |  | same day | 
| Procedure Complications |  | procedure and post-procedure complications within 30 days after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques