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Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas. (WLEvB-NBI)

This study is not yet open for participant recruitment.
Verified November 2012 by South West Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01737567
First received: November 27, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.


Condition Intervention
Colonic Adenomas
 Other: Bright Narrow Band Imaging.
Other: White Light Endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by South West Sydney Local Health District:

Primary Outcome Measures:
  • Improvement in detection of colorectal adenomas. [ Time Frame: One year ] [ Designated as safety issue: No ]
    It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.


Secondary Outcome Measures:
  • Improvement of histological prediction [ Time Frame: One year ] [ Designated as safety issue: No ]
    It is anticipated that the use of Bright Narrow Band Imaging will significantly improve the histological detection of colonic adenomas when detected as opposed to White Light Endoscopy.


Estimated Enrollment: 1000
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bright Narrow Band Imaging
Use of B-NBI to detect colonic adenomas.
 Other: Bright Narrow Band Imaging.
Using Bright Narrow Band Imaging to detect colonic adenomas.
Active Comparator: White Light Endoscopy
Use of White Light Endoscopy to detect colonic adenomas.
 Other: White Light Endoscopy
Use of White Light Endoscopy to detect colonic adenomas.

Detailed Description:

Removal of colorectal adenomas prevents occurrence of cancers [1]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers [2]. There is a need to further improve performance of colonoscopy. The use of chromoendoscopy has been shown to improve detection of flat adenomas [3]. Narrow band imaging was introduced in year 2006. It is similar to chromoendoscopy 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 chromoendoscopy.

In pooled analysis, NBI is comparable to chromoendoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas [4]. 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 [5, 6]. 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 [7].

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.

Exclusion Criteria:

  • personal history of inflammatory bowel disease, colon adenoma or cancer
  • family history of FAP or Familial nonpolyposis syndrome
  • first degree relatives having diagnosed to have colorectal carcinoma
  • no colonoscopy in past 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737567

Contacts
Contact: Rebecca Sonson, BN 98455555 ext 59779 westmeadendoscopyresearch@gmail.com
Contact: Michael Bourke, FRACP, MBBS 98455555 ext 59779 westmeadendoscopyresearch@gmail.com

Locations
Australia, New South Wales
Westmead Endoscopy Unit Not yet recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Michael Bourke, MBBS, FRACP            
Sub-Investigator: Eric Lee, FRACP, MBBS            
Sub-Investigator: Stephen Williams, FRACP, MBBS            
Sponsors and Collaborators
South West Sydney Local Health District
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01737567     History of Changes
Other Study ID Numbers: HREC/11/WMEAD/223, HREC2011/12/4.9 (3395)
Study First Received: November 27, 2012
Last Updated: November 28, 2012
Health Authority: Australia: WSLHD - HREC Westmead Hospital.

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013