ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03696992
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Colon Adenoma Procedure: Tandem colonoscopy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 894 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized design
Masking: Single (Participant)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: NBI
Tandem colonoscopy with NBI follow by WL
Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities

Active Comparator: BLI
Tandem colonoscopy with BLI follow by WLI
Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities

Experimental: WLI
Tandem colonoscopy with WLI follow by WL
Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities




Primary Outcome Measures :
  1. Proximal adenoma detection rate [ Time Frame: one day ]
    proportion of patients with proximal adenoma detected on first examination


Secondary Outcome Measures :
  1. proximal polyp detection rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected on first examination

  2. proximal adenoma miss rate [ Time Frame: one day ]
    proportion of patients with proximal adenoma detected on second examination

  3. proximal polyp miss rate [ Time Frame: one day ]
    proportion of patients with proximal polyp detected on second examination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696992


Contacts
Contact: Wai Keung Leung, MD +852 22553348 waikleung@hku.hk

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Thomas Lui, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong

Responsible Party: LEUNG Wai Keung, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03696992     History of Changes
Other Study ID Numbers: UW18-420
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by LEUNG Wai Keung, The University of Hong Kong:
colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms