White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy (WLEvsB-NBI)

A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

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

Study Overview

• Status: Recruiting
• Conditions: Adenoma Colon
• Intervention / Treatment: Diagnostic test: WLE first, then B-NBI

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Bourke, MBBS; Phone Number: 8890555

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Michael Bourke; Phone Number: 88905555

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of right sided polyp detection with WLE and B-NBI	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of the detection of SSPs in the right colon with WLE and B-NBI	1 day

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 4222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No