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Clinical Trials/NCT03448653
NCT03448653
Terminated
Not Applicable

Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps

Centre Hospitalier Departemental Vendee2 sites in 1 country314 target enrollmentJuly 9, 2018
ConditionsPolyps of Colon

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polyps of Colon
Sponsor
Centre Hospitalier Departemental Vendee
Enrollment
314
Locations
2
Primary Endpoint
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
Status
Terminated
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 9, 2018
End Date
July 12, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)

Time Frame: 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

Study Sites (2)

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