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

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ClinicalTrials.gov Identifier: NCT03448653
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Study Description
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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).


Condition or disease Intervention/treatment Phase
Polyps of Colon Other: Colonoscopy with NBI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Colonoscopy with NBI Other: Colonoscopy with NBI
Colonoscopy with NBI


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of the NBI compared to the anatomopathological analysis (= reference method) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448653


Contacts
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Contact: Chloé MOREAU 0251446327 chloe.moreau@chd-vendee.fr

Locations
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France
Centre Hospitalier Départemental Vendée Recruiting
La Roche sur Yon, France, 85925
Principal Investigator: Vincent MACE         
Centre Hospitalier Universitaire Nantes Recruiting
Nantes, France, 44000
Principal Investigator: Guillaume VELUT         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Study Director: Vincent MACE Centre Hospitalier Départemental Vendée
More Information
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03448653    
Other Study ID Numbers: CHD010-17
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps