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Slow recruitment, advances in technology
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with NBI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy with NBI | Other | Colonoscopy with NBI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | An average of 1 month |
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Pre-inclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent MACE | Centre Hospitalier Départemental Vendée | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | 85925 | France | |||
| Centre Hospitalier Universitaire Nantes |
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonoscopy With NBI | Colonoscopy with NBI: Colonoscopy with NBI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonoscopy With NBI | Colonoscopy with NBI: Colonoscopy with NBI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All polyps with histological analysis available in eligible patients | Posted | Number | 95% Confidence Interval | proportion of positive cases | An average of 1 month | polyps | polyps |
|
|
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Death, serious adverse event and other (not serious adverse event) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colonoscopy With NBI | Colonoscopy with NBI: Colonoscopy with NBI | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vincent MACE | Centre Hospitalier Départemental Vendée | 0251446572 | +33 | vincent.mace@ght85.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2021 | Sep 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Nantes |
| 44000 |
| France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| polyps |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D008919 | Investigative Techniques |