BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma (BNW)
Primary Purpose
Colon Adenoma
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tandem colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Age 40 or above
- scheduled for colonoscopy
Exclusion Criteria:
- 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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
NBI
BLI
WLI
Arm Description
Tandem colonoscopy with NBI follow by WL
Tandem colonoscopy with BLI follow by WLI
Tandem colonoscopy with WLI follow by WL
Outcomes
Primary Outcome Measures
Proximal adenoma detection rate
proportion of patients with proximal adenoma detected on first examination
Secondary Outcome Measures
proximal polyp detection rate
proportion of patients with proximal polyp detected on first examination
proximal adenoma miss rate
proportion of patients with proximal adenoma detected on second examination
proximal polyp miss rate
proportion of patients with proximal polyp detected on second examination
Full Information
NCT ID
NCT03696992
First Posted
September 27, 2018
Last Updated
April 19, 2022
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03696992
Brief Title
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma
Acronym
BNW
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma
Keywords
colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized design
Masking
Participant
Allocation
Randomized
Enrollment
884 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBI
Arm Type
Experimental
Arm Description
Tandem colonoscopy with NBI follow by WL
Arm Title
BLI
Arm Type
Active Comparator
Arm Description
Tandem colonoscopy with BLI follow by WLI
Arm Title
WLI
Arm Type
Experimental
Arm Description
Tandem colonoscopy with WLI follow by WL
Intervention Type
Procedure
Intervention Name(s)
Tandem colonoscopy
Intervention Description
Tandem colonoscopy with different image modalities
Primary Outcome Measure Information:
Title
Proximal adenoma detection rate
Description
proportion of patients with proximal adenoma detected on first examination
Time Frame
one day
Secondary Outcome Measure Information:
Title
proximal polyp detection rate
Description
proportion of patients with proximal polyp detected on first examination
Time Frame
one day
Title
proximal adenoma miss rate
Description
proportion of patients with proximal adenoma detected on second examination
Time Frame
one day
Title
proximal polyp miss rate
Description
proportion of patients with proximal polyp detected on second examination
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 40 or above
scheduled for colonoscopy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Keung Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma
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