Polyps of Colon
Conditions
Brief summary
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).
Interventions
OTHERColonoscopy with NBI
Colonoscopy with NBI
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-inclusion criteria: * Major patient with a colonoscopy scheduled in one of the participating hospitals (CHD Vendée and CHU Nantes). * Patient who agreed to participate in the study and gave his express consent * Patient affiliated with a social security system or beneficiary of a scheme Inclusion Criteria: * Patient with 1 or more polyps less than 20 mm observed during colonoscopy
Exclusion criteria
* Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms * Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis * Patient with familial adenomatous polyposis * Pregnant or lactating woman * Minor patient * Major patient under tutorship, curatorship, or deprived of liberty * Patient unable to understand protocol and / or give express consent * Patient not affiliated with a social security system or beneficiary of such a scheme * Patient hospitalized or treated without their consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method) | An average of 1 month | Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colonoscopy With NBI Colonoscopy with NBI: Colonoscopy with NBI | 312 |
| Total | 312 |
Baseline characteristics
| Characteristic | Colonoscopy With NBI |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 312 Participants |
| Region of Enrollment France | 312 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: All polyps with histological analysis available in eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Colonoscopy With NBI | Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method) | 0.844 proportion of positive cases |