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

Polyps of Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03448653
• Other study ID #: CHD010-17
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: July 12, 2022

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 297
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps
• Polyps of Colon

Intervention

Other:
• Colonoscopy with NBI
Colonoscopy with NBI

Locations

Country	Name	City	State
France	Centre Hospitalier Départemental Vendée	La Roche sur Yon
France	Centre Hospitalier Universitaire Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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