The Use of Narrow Band Imaging in Screening Colonoscopy

March 30, 2021 updated by: Vittorio Terruzzi, Valduce Hospital

The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
standard white light
Experimental: 2
Narrow Band Imaging
Procedure: Narrow Band Imaging
Narrow Band Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection
Time Frame: duration of colonoscopy procedure
Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization
duration of colonoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Flat and/or Depressed Adenomas
Time Frame: duration of colonoscopy procedure
number of patients with at least 1 flat and/or depressed adenoma
duration of colonoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NBI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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