Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.

NCT ID: NCT01737567

Last Updated: 2025-03-27

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2024-06-30

Brief Summary

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Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.

Detailed Description

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Removal of colorectal adenomas prevents occurrence of cancers \[1\]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers \[2\]. There is a need to further improve performance of colonoscopy. The use of chromoendoscopy has been shown to improve detection of flat adenomas \[3\]. Narrow band imaging was introduced in year 2006. It is similar to chromoendoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromoendoscopy.

In pooled analysis, NBI is comparable to chromoendoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas \[4\]. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI \[5, 6\]. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE \[7\].

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

Conditions

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Colonic Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Bright Narrow Band Imaging

Use of B-NBI to detect colonic adenomas.

Group Type EXPERIMENTAL

Bright Narrow Band Imaging.

Intervention Type OTHER

Using Bright Narrow Band Imaging to detect colonic adenomas.

White Light Endoscopy

Use of White Light Endoscopy to detect colonic adenomas.

Group Type ACTIVE_COMPARATOR

White Light Endoscopy

Intervention Type OTHER

Use of White Light Endoscopy to detect colonic adenomas.

Interventions

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Bright Narrow Band Imaging.

Using Bright Narrow Band Imaging to detect colonic adenomas.

Intervention Type OTHER

White Light Endoscopy

Use of White Light Endoscopy to detect colonic adenomas.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic subjects undergoing screening colonoscopy, age \> 50, average risk subjects and, ability to provide a written consent to trial participation.

Exclusion Criteria

* personal history of inflammatory bowel disease, colon adenoma or cancer
* family history of FAP or Familial nonpolyposis syndrome
* first degree relatives having diagnosed to have colorectal carcinoma
* no colonoscopy in past 5 years
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Professor Michael Bourke

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC2011/12/4.9 (3395)

Identifier Type: OTHER

Identifier Source: secondary_id

HREC/11/WMEAD/223

Identifier Type: -

Identifier Source: org_study_id

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