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

NCT03448653 | Terminated Results

• 1 other identifier: CHD010-17
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 2

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).

Conditions

Polyps of Colon

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Colonoscopy with NBI

EXPERIMENTAL

Other: Colonoscopy with NBI

Interventions

Colonoscopy with NBI OTHER

Colonoscopy with NBI

Colonoscopy with NBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient with 1 or more polyps less than 20 mm observed during colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Universitaire Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy; Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Optical Imaging; Diagnostic Imaging; Investigative Techniques

Results Point of Contact

• Title: Dr. Vincent MACE
• Organization: Centre Hospitalier Départemental Vendée

vincent.mace@ght85.fr

0251446572

Study Officials

• Vincent MACE

  Centre Hospitalier Départemental Vendée

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 28, 2018
• Study Start: July 9, 2018
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-10

Locations

FR (2)