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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow band imaging colonoscope | Experimental | narrow band imaging colonoscope |
|
| White Light | No Intervention | Conventional White Light Examination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow band imaging colonoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neoplasm Miss Rate | same day |
| Measure | Description | Time Frame |
|---|---|---|
| Neoplasm Detection Rates | same day | |
| Completion of Examinations | same day | |
| Procedure Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Soetikno, MD, MS | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VAPaloAltoHCS | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18523025 | Derived | Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Band Imaging Colonoscope | Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): 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. |
| FG001 | White Light | Conventional White Light Examination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Band Imaging Colonoscope | Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neoplasm Miss Rate | Posted | Number | 95% Confidence Interval | Miss rate percentage | same day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Band Imaging Colonoscope | Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tonya Kaltenbach | SF VA Medical Center | 415-221-4810 | 24103 | tonya.kaltenbach@va.gov |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
|
| procedure and post-procedure complications within 30 days after colonoscopy |
| BG001 | White Light | Conventional White Light Examination |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Neoplasm Detection Rates | We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening). | Posted | Count of Participants | Participants | same day |
|
|
|
| Secondary | Completion of Examinations | Posted | Count of Participants | Participants | same day |
|
|
|
| Secondary | Procedure Complications | Posted | Count of Participants | Participants | procedure and post-procedure complications within 30 days after colonoscopy |
|
|
|
| 0 |
| 142 |
| 0 |
| 142 |
| EG001 | White Light | Conventional White Light Examination | 0 | 142 | 0 | 142 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Screening |
|
|
| Non-Screening |
|
|