Comparison of ADR Using NBI Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies

March 17, 2018 updated by: Martin Bürger, Jena University Hospital

Comparison of Adenoma Detection Rate Using Narrow Band Imaging Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies

The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. Therefore, improved imaging modalities have been introduced to increase adenoma detection rate (ADR) during screening and surveillance colonoscopies. Recently, narrow band imaging (NBI; Exera II series, Olympus Corporation) was not significantly better than high definition white light colonoscopy (WLC) for the detection of patients with colorectal polyps, or colorectal adenomas1. However, Olympus' current Exera III series is characterized by better illumination of the bowel lumen and may be associated with a higher ADR than high definition WLC.

Methods:

Investigators performed a prospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for screening or surveillance colonoscopy between January and November 2015 in daily clinical practice. Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal of the colonoscope (Exera III series, Olympus Corporation).

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thueringia
      • Jena, Thueringia, Germany, 07743
        • University Clinic Jena

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Screening colonoscopies

Exclusion Criteria:

  • Insufficient bowel cleansing
  • Age under 55years

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
Active Comparator: HD white light
Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal
Device: HD white light or NBI
Use of NBI or HD white light
Active Comparator: HD narrow band imaging
Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal
Device: HD white light or NBI
Use of NBI or HD white light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: up to 60min
Adenoma detection rate
up to 60min

Collaborators and Investigators

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

Sponsor

Jena University Hospital

Investigators

  • Study Director: Carsten Schmidt, MD, University Clinic Jena

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

January 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 4, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NBI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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