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

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

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).

Study Overview

• Status: Terminated
• Conditions: Polyps of Colon
• Intervention / Treatment: Other: Colonoscopy with NBI

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Roche sur Yon, France, 85925
    • Centre Hospitalier Départemental VENDEE
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy with NBI	Other: Colonoscopy with NBI; Colonoscopy with NBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Study Director: Vincent MACE, Centre Hospitalier Départemental VENDEE

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: CHD010-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No