Clinical Evaluation of Narrow Band Imaging Colonoscope
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Narrow band imaging colonoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques
Eligibility Criteria
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
Sites / Locations
- VAPaloAltoHCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Narrow band imaging colonoscope
White Light
Arm Description
narrow band imaging colonoscope
Conventional White Light Examination
Outcomes
Primary Outcome Measures
Neoplasm Miss Rate
Secondary Outcome Measures
Neoplasm Detection Rates
Completion of Examinations
Procedure Complications
Full Information
NCT ID
NCT00628147
First Posted
February 25, 2008
Last Updated
January 17, 2017
Sponsor
VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT00628147
Brief Title
Clinical Evaluation of Narrow Band Imaging Colonoscope
Official Title
Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrow band imaging colonoscope
Arm Type
Experimental
Arm Description
narrow band imaging colonoscope
Arm Title
White Light
Arm Type
No Intervention
Arm Description
Conventional White Light Examination
Intervention Type
Device
Intervention Name(s)
Narrow band imaging colonoscope
Other Intervention Name(s)
CF-H180AL, CF-Q180AL, Evis Exera II CV-180
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neoplasm Miss Rate
Time Frame
same day
Secondary Outcome Measure Information:
Title
Neoplasm Detection Rates
Time Frame
same day
Title
Completion of Examinations
Time Frame
same day
Title
Procedure Complications
Time Frame
procedure and post-procedure complications within 30 days after colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Soetikno, MD, MS
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAPaloAltoHCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18523025
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Evaluation of Narrow Band Imaging Colonoscope
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