Back to resultsContribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)
Primary Purpose
Polyps of Colon
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colonoscopy with NBI
Sponsored by
About this trial
This is an interventional prevention trial for Polyps of Colon
Eligibility 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
Sites / Locations
- Centre Hospitalier Départemental Vendée
- Centre Hospitalier Universitaire Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colonoscopy with NBI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03448653
First Posted
February 21, 2018
Last Updated
July 12, 2022
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT03448653
Brief Title
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)
Official Title
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment, advances in technology
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps of Colon
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colonoscopy with NBI
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Colonoscopy with NBI
Intervention Description
Colonoscopy with NBI
Primary Outcome Measure Information:
Title
Sensitivity of the NBI compared to the anatomopathological analysis (= reference method)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent MACE
Organizational Affiliation
Centre Hospitalier Départemental Vendée
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)
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