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The Use of Narrow Band Imaging in Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT00908648
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : May 27, 2009
Last Update Posted : May 27, 2009
Sponsor:
Information provided by:
Valduce Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Procedure: Narrow Band Imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
standard white light
Experimental: 2
Narrow Band Imaging
Procedure: Narrow Band Imaging
Narrow Band Imaging



Primary Outcome Measures :
  1. Adenoma Detection [ Time Frame: duration of colonoscopy procedure ]

Secondary Outcome Measures :
  1. Detection of Flat and/or Depressed Adenomas [ Time Frame: duration of colonoscopy procedure ]


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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Vittorio Terruzzi, MD., Valduce Hospital, Department of Gastroenterology
ClinicalTrials.gov Identifier: NCT00908648     History of Changes
Other Study ID Numbers: NBI-01
First Posted: May 27, 2009    Key Record Dates
Results First Posted: May 27, 2009
Last Update Posted: May 27, 2009
Last Verified: April 2009

Keywords provided by Valduce Hospital:
screening colonoscopy
narrow band imaging