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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 (WLEvsB-NBI)

Primary Purpose

Adenoma Colon

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
WLE first, then B-NBI
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma Colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Asymptomatic subjects undergoing screening colonoscopy, age > 50. Avaverage 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

Sites / Locations

  • Westmead HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First withdrawal - White light endoscopy

First withdrawal - Bright Narrow Band Imagin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2023
Last Updated
July 6, 2023
Sponsor
Western Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT05935124
Brief Title
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
Acronym
WLEvsB-NBI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed Description
Removal of colorectal adenomas prevents occurrence of cancers [1]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers [2]. 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 (3). 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 (4,5) The use of chromo-endoscopy has been shown to improve detection of flat adenomas [6]. 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 [7]. 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 [8,9]. 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 [10]. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized crossover study
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First withdrawal - White light endoscopy
Arm Type
Other
Arm Description
white light (WLE) high definition colonoscope (Olympus 190 series) first and then B-NBI
Arm Title
First withdrawal - Bright Narrow Band Imagin
Arm Type
Other
Arm Description
B-NBI first and then WLE with the same colonoscope.
Intervention Type
Diagnostic Test
Intervention Name(s)
WLE first, then B-NBI
Primary Outcome Measure Information:
Title
Rate of right sided polyp detection with WLE and B-NBI
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Rate of the detection of SSPs in the right colon with WLE and B-NBI
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Asymptomatic subjects undergoing screening colonoscopy, age > 50. Avaverage 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Goodrick, BN
Phone
8890555
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Goodrick
Phone
88905555

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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