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The Use of Narrow Band Imaging in Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Valduce Hospital
ClinicalTrials.gov Identifier:
NCT00908648
First received: January 22, 2009
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  Purpose

Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.


Condition Intervention
Colonoscopy
 Procedure: Narrow Band Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • Adenoma Detection [ Time Frame: duration of colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of Flat and/or Depressed Adenomas [ Time Frame: duration of colonoscopy procedure ] [ Designated as safety issue: No ]

Enrollment: 206
Arms Assigned Interventions
No Intervention: 1
standard white light
Experimental: 2
Narrow Band Imaging
 Procedure: Narrow Band Imaging
Narrow Band Imaging

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50-69 year-old asymptomatic subjects at average-risk of CRC
  • positive FOBT participating in a national mass-screening program and referred for colonoscopy

Exclusion Criteria:

  • ongoing anticoagulation therapy
  • inadequate bowel cleansing
  • incomplete colonoscopy
  • refusing to participate
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Vittorio Terruzzi, MD., Valduce Hospital, Department of Gastroenterology
ClinicalTrials.gov Identifier: NCT00908648     History of Changes
Other Study ID Numbers: NBI-01
Study First Received: January 22, 2009
Results First Received: January 22, 2009
Last Updated: April 2, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Valduce Hospital:
screening colonoscopy
narrow band imaging

ClinicalTrials.gov processed this record on June 17, 2013