An interventional study of Colonoscopy with NBI in Polyps of Colon, sponsored by Centre Hospitalier Departemental Vendee. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Diagnostic
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.
The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.
The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).
326 studies on the registry are indexed under Colonic Polyps; 53 are open to participants now.
This study's enrollment of 314 is above the median of 264 across 221 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Pre-inclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Other: Colonoscopy with NBI
Colonoscopy with NBI
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology
Time frame: An average of 1 month
| Milestone | Colonoscopy With NBI |
|---|---|
| Started | 314 |
| Completed | 314 |
| Not completed | 0 |
Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology
| proportion of positive cases | Colonoscopy With NBI |
|---|---|
| Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method) | 0.844 (0.803 to 0.879) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colonoscopy With NBI | — | — | — |
| Age, Continuous(years) | Colonoscopy With NBI |
|---|---|
| Mean | 67 ± 9 |
| Sex: Female, Male(Participants) | Colonoscopy With NBI |
|---|---|
| Female | 117 |
| Male | 195 |
| Ethnicity (NIH/OMB)(Participants) | Colonoscopy With NBI |
|---|---|
| Hispanic or Latino | NA |
| Not Hispanic or Latino | NA |
| Unknown or Not Reported | 312 |
| Region of Enrollment(participants) | Colonoscopy With NBI |
|---|---|
| France | 312 |
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Departemental Vendee