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Trial Title:
A Randomized Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy
NCT ID:
NCT05935124
Condition:
Adenoma Colon
Conditions: Official terms:
Adenoma
Colonic Polyps
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized crossover study
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
WLE first, then B-NBI
Arm group label:
First withdrawal - Bright Narrow Band Imagin
Arm group label:
First withdrawal - White light endoscopy
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. 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Westmead Hospital
Address:
City:
Sydney
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kathleen Goodrick
Phone:
88905555
Start date:
August 1, 2015
Completion date:
November 2025
Lead sponsor:
Agency:
Western Sydney Local Health District
Agency class:
Other
Source:
Western Sydney Local Health District
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05935124
