NCT03696992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
884

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

September 27, 2018

Last Update Submit

April 19, 2022

Conditions

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Proximal adenoma detection rate

    proportion of patients with proximal adenoma detected on first examination

    one day

Secondary Outcomes (3)

  • proximal polyp detection rate

    one day

  • proximal adenoma miss rate

    one day

  • proximal polyp miss rate

    one day

Study Arms (3)

NBI

EXPERIMENTAL

Tandem colonoscopy with NBI follow by WL

Procedure: Tandem colonoscopy

BLI

ACTIVE COMPARATOR

Tandem colonoscopy with BLI follow by WLI

Procedure: Tandem colonoscopy

WLI

EXPERIMENTAL

Tandem colonoscopy with WLI follow by WL

Procedure: Tandem colonoscopy

Interventions

Tandem colonoscopy with different image modalities

BLINBIWLI

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 or above
  • scheduled for colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

Study Officials

  • Wai Keung Leung, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective randomized design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 5, 2018

Study Start

November 8, 2018

Primary Completion

February 1, 2022

Study Completion

April 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations