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BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma (BNW)

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ClinicalTrials.gov Identifier: NCT03696992
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE November 8, 2018
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Proximal adenoma detection rate [ Time Frame: one day ]
proportion of patients with proximal adenoma detected on first examination
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Proximal adenoma detection rate [ Time Frame: one day ]
proportion of patients with proximal adenoma detected
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • proximal polyp detection rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected on first examination
  • proximal adenoma miss rate [ Time Frame: one day ]
    proportion of patients with proximal adenoma detected on second examination
  • proximal polyp miss rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected on second examination
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • proximal polyp detection rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected
  • proximal adenoma miss rate [ Time Frame: one day ]
    proportion of patients with proximal adenoma detected
  • proximal polyp miss rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma
Official Title  ICMJE Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized design
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Colon Adenoma
Intervention  ICMJE Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities
Study Arms  ICMJE
  • Experimental: NBI
    Tandem colonoscopy with NBI follow by WL
    Intervention: Procedure: Tandem colonoscopy
  • Active Comparator: BLI
    Tandem colonoscopy with BLI follow by WLI
    Intervention: Procedure: Tandem colonoscopy
  • Experimental: WLI
    Tandem colonoscopy with WLI follow by WL
    Intervention: Procedure: Tandem colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
894
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
1200
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wai Keung Leung, MD +852 22553348 waikleung@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03696992
Other Study ID Numbers  ICMJE UW18-420
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LEUNG Wai Keung, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Queen Mary Hospital, Hong Kong
Investigators  ICMJE
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP