Colonic AdenomasWLEvB-NBINCT01737567
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
A study testing Bright Narrow Band Imaging. and White Light Endoscopy in people with Colonic Adenomas, run by Professor Michael Bourke at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Adenomas
- What is being tested?
- Bright Narrow Band Imaging. and White Light Endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2014to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Colonic Adenomas
- Being tested
- Bright Narrow Band Imaging., White Light Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Narrow Band Imaging.Other
Using Bright Narrow Band Imaging to detect colonic adenomas.
White Light EndoscopyOther
Use of White Light Endoscopy to detect colonic adenomas.
| Study group | Role | What they receive |
|---|---|---|
| Bright Narrow Band Imaging | Experimental | Use of B-NBI to detect colonic adenomas. Receives: Other: Bright Narrow Band Imaging. |
| White Light Endoscopy | Active comparator | Use of White Light Endoscopy to detect colonic adenomas. Receives: Other: White Light Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in detection of colorectal adenomas.
It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
Measured: One year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startFeb 2014
- Primary completionJun 2021
- Study completionJun 2024 (estimated)
Why it stopped: similar study is progressing instead
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic AdenomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737567
- Sponsor's protocol ID
- HREC/11/WMEAD/223
- Other IDs
- HREC2011/12/4.9 (3395)
- Acronym
- WLEvB-NBI
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2012
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01737567
- Acronym / sponsor ID
- WLEvB-NBI / HREC/11/WMEAD/223
- Conditions
- Colonic Adenomas
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: similar study is progressing instead
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Narrow Band Imaging | Experimental | Other: Bright Narrow Band Imaging.Use of B-NBI to detect colonic adenomas. |
| White Light Endoscopy | Active comparator | Other: White Light EndoscopyUse of White Light Endoscopy to detect colonic adenomas. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Narrow Band Imaging.Using Bright Narrow Band Imaging to detect colonic adenomas. | Other | Bright Narrow Band Imaging |
| White Light EndoscopyUse of White Light Endoscopy to detect colonic adenomas. | Other | White Light Endoscopy |
Primary outcome
Improvement in detection of colorectal adenomas.
Time frame: One year
It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
1 secondary outcome
Improvement of histological prediction
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Narrow Band Imaging. and White Light Endoscopy in people with Colonic Adenomas, run by Professor Michael Bourke at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in detection of colorectal adenomas. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.