N/A
N=804
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01572428 ↗Enrolled (actual)
804
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Total Number of Serrated Lesions Proximal to the Sigmoid Colon — 204; 158; 95; 59 Serrated Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inspection with Narrow-Band Imaging(NBI) (Procedure); Standard White Light (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Serrated Lesions Proximal to the Sigmoid Colon |
204; 158; 95; 59; 39; 20 | — |
| PRIMARY Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient |
0.51; 0.39; 0.24; 0.15; 0.10; 0.05 | — |
| SECONDARY Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon |
105; 107; 60; 45; 25; 19 | — |
| SECONDARY Total Number of Conventional Adenomas in Entire Colon |
438; 434; 110; 90; 29; 22 | — |
| SECONDARY Number of Conventional Adenomas Per Patient in Entire Colon |
1.1; 1.08; 0.28; 0.22; 0.07; 0.05 | — |
| SECONDARY Patients With 1 or More Conventional Adenomas |
202; 189; 84; 61; 25; 18 | — |
Summary
This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.
Eligibility Criteria
Inclusion Criteria
- Age 50-85
- Intact colon and rectum
- American Society of Anesthesiology risk class 1, 2 or 3
Exclusion Criteria
- No prior surgical resection of colon or rectum
Data sourced from ClinicalTrials.gov (NCT01572428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.