Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas. (WLEvB-NBI)
Primary Purpose
Colonic Adenomas
Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Bright Narrow Band Imaging.
White Light Endoscopy
Sponsored by
About this trial
This is an interventional screening trial for Colonic Adenomas
Eligibility Criteria
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
Sites / Locations
- Westmead Endoscopy Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bright Narrow Band Imaging
White Light Endoscopy
Arm Description
Use of B-NBI to detect colonic adenomas.
Use of White Light Endoscopy to detect colonic adenomas.
Outcomes
Primary Outcome Measures
Improvement in detection of colorectal adenomas.
It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
Secondary Outcome Measures
Improvement of histological prediction
It is anticipated that the use of Bright Narrow Band Imaging will significantly improve the histological detection of colonic adenomas when detected as opposed to White Light Endoscopy.
Full Information
NCT ID
NCT01737567
First Posted
November 27, 2012
Last Updated
June 28, 2023
Sponsor
Professor Michael Bourke
1. Study Identification
Unique Protocol Identification Number
NCT01737567
Brief Title
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
Acronym
WLEvB-NBI
Official Title
A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenomas
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bright Narrow Band Imaging
Arm Type
Experimental
Arm Description
Use of B-NBI to detect colonic adenomas.
Arm Title
White Light Endoscopy
Arm Type
Active Comparator
Arm Description
Use of White Light Endoscopy to detect colonic adenomas.
Intervention Type
Other
Intervention Name(s)
Bright Narrow Band Imaging.
Intervention Description
Using Bright Narrow Band Imaging to detect colonic adenomas.
Intervention Type
Other
Intervention Name(s)
White Light Endoscopy
Intervention Description
Use of White Light Endoscopy to detect colonic adenomas.
Primary Outcome Measure Information:
Title
Improvement in detection of colorectal adenomas.
Description
It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Improvement of histological prediction
Description
It is anticipated that the use of Bright Narrow Band Imaging will significantly improve the histological detection of colonic adenomas when detected as opposed to White Light Endoscopy.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Westmead Endoscopy Unit
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
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