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RecruitingNCT05935124WLEvsB-NBIUpdated Mar 30, 2025

White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

An interventional study of WLE first, then B-NBI in Adenoma Colon, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

Read the detailed description

Removal of colorectal adenomas prevents occurrence of cancers. It is recognized that colonoscopy can miss colorectal adenomas and early cancers. Proximal colon polyp detection rate is lower compared to distal colon detection rates. This may be partially due to the higher prevalence of flat polyps and sessile serrated adenomas (SSAs) which are harder to visualize. There is a need to further improve performance of colonoscopy. A second evaluation of the right colon within the same procedure may yield an additional detection rate of 5-10%, however retro-flexion has not proven to be superior to a second forward viewing examination. The use of chromo-endoscopy has been shown to improve detection of flat adenomas. Narrow band imaging was introduced in year 2006. It is similar to chromo-endoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromo-endoscopy. In pooled analysis, NBI is comparable to chromo-endoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE.

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

02

Conditions studied

  • Adenoma Colon
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Asymptomatic subjects undergoing screening colonoscopy
  • age > 50.
  • average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of FAP or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years and, ability to provide a written consent to trial participation

Exclusion criteria

Exclusion Criteria:

  • unable to consent
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (estimated)

Study arms

  • Other
    First withdrawal - White light endoscopy

    white light (WLE) high definition colonoscope (Olympus 190 series) first and then B-NBI

    Diagnostic Test: WLE first, then B-NBI

  • Other
    First withdrawal - Bright Narrow Band Imagin

    B-NBI first and then WLE with the same colonoscope.

    Diagnostic Test: WLE first, then B-NBI

Interventions

  • Diagnostic testWLE first, then B-NBI
05

What researchers measure

Primary outcomes

  1. Rate of right sided polyp detection with WLE and B-NBI

    Time frame: 1 day

Secondary outcomes

  1. Rate of the detection of SSPs in the right colon with WLE and B-NBI

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
  • Westmead Hospital
    Sydney, New South Wales 2145, Australia
    • Michael Bourke · Contact · 88905555
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05935124
Lead sponsor
Western Sydney Local Health District
Responsible party
Professor Michael Bourke (Director of Endoscopy, Western Sydney Local Health District) — Principal investigator
First posted
Jul 7, 2023
Start date
Aug 1, 2015
Primary completion
May 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Mar 30, 2025

Study contacts

Michael Bourke, MBBS
Contact
8890555

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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