Colon AdenomaBNWNCT03696992
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma
A study testing Tandem colonoscopy in people with Colon Adenoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- Tandem colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Nov 2018to 1 Apr 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 or above
- scheduled for colonoscopy
Who cannot join
- unable to provide informed consent
- have undergone previous colorectal resection,
- personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.
- Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
- poor bowel preparation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study
This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.
Read the detailed description
Study population:
Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2.
Study design and randomization:
This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment.
- Conditions
- Colon Adenoma
- Being tested
- Tandem colonoscopy
- Keywords
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem colonoscopyProcedure or surgery
Tandem colonoscopy with different image modalities
| Study group | Role | What they receive |
|---|---|---|
| NBI | Experimental | Tandem colonoscopy with NBI follow by WL Receives: Procedure: Tandem colonoscopy |
| BLI | Active comparator | Tandem colonoscopy with BLI follow by WLI Receives: Procedure: Tandem colonoscopy |
| WLI | Experimental | Tandem colonoscopy with WLI follow by WL Receives: Procedure: Tandem colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal adenoma detection rate
proportion of patients with proximal adenoma detected on first examination
Measured: one day
Secondary outcomes (3)
proximal polyp detection rate
proportion of patients with proximal polyp detected on first examination
Measured: one day
proximal adenoma miss rate
proportion of patients with proximal adenoma detected on second examination
Measured: one day
proximal polyp miss rate
proportion of patients with proximal polyp detected on second examination
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start8 Nov 2018
- Primary completion1 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, LEUNG Wai Keung, The University of Hong Kong
- Investigators
- Wai Keung Leung, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696992
- Sponsor's protocol ID
- UW18-420
- Acronym
- BNW
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2018
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung WK, Tsui VWM, Mak LL, Cheung MK, Hui CK, Lam CP, Wong SY, Liu KS, Ko MK, To EW, Guo CG, Lui TK. Blue-light imaging or narrow-band imaging for proximal colonic lesions: a prospective randomized tandem colonoscopy study. Gastrointest Endosc. 2023 Nov;98(5):813-821.e3. doi: 10.1016/j.gie.2023.06.004. Epub 2023 Jun 10.
PubMed 37307902
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03696992
- Acronym / sponsor ID
- BNW / UW18-420
- Conditions
- Colon Adenoma
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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.
This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.
Detailed description
Study population:
Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2.
Study design and randomization:
This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective randomized design
| Arm | Type | Receives |
|---|---|---|
| NBI | Experimental | Procedure: Tandem colonoscopyTandem colonoscopy with NBI follow by WL |
| BLI | Active comparator | Procedure: Tandem colonoscopyTandem colonoscopy with BLI follow by WLI |
| WLI | Experimental | Procedure: Tandem colonoscopyTandem colonoscopy with WLI follow by WL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40 or above
- scheduled for colonoscopy
Key exclusion criteria (5 listed)
- unable to provide informed consent
- have undergone previous colorectal resection,
- personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.
- Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
- poor bowel preparation
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 |
|---|---|---|
| Tandem colonoscopyTandem colonoscopy with different image modalities | Procedure or surgery | BLI, NBI, WLI |
Primary outcome
Proximal adenoma detection rate
Time frame: one day
proportion of patients with proximal adenoma detected on first examination
3 secondary outcomes
proximal polyp detection rate
Time frame: one day
proximal adenoma miss rate
Time frame: one day
proximal polyp miss rate
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 37307902Leung WK, Tsui VWM, Mak LL, Cheung MK, Hui CK, Lam CP, Wong SY, Liu KS, Ko MK, To EW, Guo CG, Lui TK. Blue-light imaging or narrow-band imaging for proximal colonic lesions: a prospective randomized tandem colonoscopy study. Gastrointest Endosc. 2023 Nov;98(5):813-821.e3. doi: 10.1016/j.gie.2023.06.004. Epub 2023 Jun 10.
- Individual participant dataSharing planned: No
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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.
Wai Keung Leung, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tandem colonoscopy in people with Colon Adenoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2022. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proximal adenoma detection rate (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696992, which also lists 1 linked publication.
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 21 Apr 2022.