Colonic Neoplasms
Conditions
Keywords
colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques
Brief summary
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
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.
Interventions
DEVICENarrow band imaging colonoscope
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.
Sponsors
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neoplasm Miss Rate | same day |
Secondary
| Measure | Time frame |
|---|---|
| Neoplasm Detection Rates | same day |
| Completion of Examinations | same day |
| Procedure Complications | procedure and post-procedure complications within 30 days after colonoscopy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 142 |
| White Light Conventional White Light Examination | 142 |
| Total | 284 |
Baseline characteristics
| Characteristic | Narrow Band Imaging Colonoscope | White Light | Total |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 |
| Gender Female | 5 Participants | 4 Participants | 9 Participants |
| Gender Male | 137 Participants | 138 Participants | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 142 | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 | 0 / 142 |
Outcome results
Primary
Neoplasm Miss Rate
Time frame: same day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narrow Band Imaging Colonoscope | Neoplasm Miss Rate | 12.6 Miss rate percentage |
| White Light | Neoplasm Miss Rate | 12.1 Miss rate percentage |
Secondary
Completion of Examinations
Time frame: same day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Narrow Band Imaging Colonoscope | Completion of Examinations | 135 Participants |
| White Light | Completion of Examinations | 141 Participants |
Secondary
Neoplasm Detection Rates
Time frame: same day
Population: We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Narrow Band Imaging Colonoscope | Neoplasm Detection Rates | Overall | 69 Participants |
| Narrow Band Imaging Colonoscope | Neoplasm Detection Rates | Screening | 29 Participants |
| Narrow Band Imaging Colonoscope | Neoplasm Detection Rates | Non-Screening | 40 Participants |
| White Light | Neoplasm Detection Rates | Overall | 66 Participants |
| White Light | Neoplasm Detection Rates | Screening | 31 Participants |
| White Light | Neoplasm Detection Rates | Non-Screening | 35 Participants |
Secondary
Procedure Complications
Time frame: procedure and post-procedure complications within 30 days after colonoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Narrow Band Imaging Colonoscope | Procedure Complications | 0 Participants |
| White Light | Procedure Complications | 0 Participants |