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

Not Applicable

Terminated

• Conditions: Polyps of Colon
• Interventions: Other: Colonoscopy with NBI

• Registration Number: NCT03448653
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Study Start: 2018-07-09
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Results First Submitted: 2024-07-10
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-11-28
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonoscopy with NBI	Colonoscopy with NBI	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centre Hospitalier Départemental Vendée; 🇫🇷 La Roche sur Yon, France

Centre Hospitalier Universitaire Nantes; 🇫🇷 Nantes, France