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

NCT ID: NCT03081975

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Narrow Band Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HD white light

Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal

Group Type ACTIVE_COMPARATOR

HD white light or NBI

Intervention Type DEVICE

Use of NBI or HD white light

HD narrow band imaging

Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal

Group Type ACTIVE_COMPARATOR

HD white light or NBI

Intervention Type DEVICE

Use of NBI or HD white light

Interventions

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HD white light or NBI

Use of NBI or HD white light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Screening colonoscopies

Exclusion Criteria

* Insufficient bowel cleansing
* Age under 55years
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Bürger

Narrow band imaging does not increase adenoma detection rate compared to high definition white light colonoscopy in screening and surveillance colonoscopies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carsten Schmidt, MD

Role: STUDY_DIRECTOR

University Clinic Jena

Locations

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University Clinic Jena

Jena, Thueringia, Germany

Site Status

Countries

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Germany

References

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Burger M, Weber M, Petersen I, Stallmach A, Schmidt C. Adenoma detection rate using narrow-band imaging is inferior to high-definition white light colonoscopy in screening and surveillance colonoscopies in daily clinical care: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 12;101(32):e29858. doi: 10.1097/MD.0000000000029858.

Reference Type DERIVED
PMID: 35960070 (View on PubMed)

Other Identifiers

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NBI01

Identifier Type: -

Identifier Source: org_study_id

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