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

Centre Hospitalier Departemental Vendee

Status: Terminated

Conditions: Polyps of Colon

Treatments: Other: Colonoscopy with NBI

Study type: Interventional

Funder types: Other

Identifiers

NCT03448653

CHD010-17

Details and patient eligibility

About

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).

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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314 participants in 1 patient group

Colonoscopy with NBI

Experimental group

Treatment:

Other: Colonoscopy with NBI