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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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2015-08-01

    Primary completion: 2025-05-01

    Study completion finish: 2025-11-01

    study type

    Study type

    DIAGNOSTIC

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05935124

    Intervention or treatment

    DIAGNOSTIC_TEST: WLE first, then B-NBI

    Conditions

    • Adenoma Colon

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    Select from list below to view details:

    • Westmead Hospital

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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
    • Not Specified
    OTHER: First withdrawal - Bright Narrow Band Imagin
    • B-NBI first and then WLE with the same colonoscope.
    DIAGNOSTIC_TEST: WLE first, then B-NBI
    • Not Specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Rate of right sided polyp detection with WLE and B-NBINot Specified1 day

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Rate of the detection of SSPs in the right colon with WLE and B-NBINot Specified1 day

    Frequently Asked Questions

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    References

    Clinical Trials Gov: 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

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