Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01422577
First received: August 2, 2011
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology that enables endoscopists to obtain better images in suboptimal conditions. The study proposes to compare the performance of colonoscopy using either white light or bright NBI in subjects undergoing screening colonoscopy in search for colon adenomas.

Purpose

To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average risk subjects undergoing screening colonoscopy.


Condition Intervention
Colonic Adenomas
Device: Bright Narrow Band Imaging
Device: White light Endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized 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:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Colorectal adenoma detection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    compare the rate in colorectal adenoma detection between B-NBI and conventional colonoscopy


Secondary Outcome Measures:
  • 1. Rate in the detection of advanced neoplasms (defined by adenomas >10 mm in size, with high grade dysplasia or with >25% villous features). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    compare the advanced neoplasm detection rate

  • 2. Sensitivity and specificity of either image modality in the diagnosis of malignant adenomas using pathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    compare the sensitivity and specificity between B-NBI and conventional colonoscopy


Estimated Enrollment: 1000
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bright Narrow Band Imaging
Bright Narrow Band Imaging
Device: Bright Narrow Band Imaging
It is a High Definition system with narrow band imaging option in th endoscope.
Active Comparator: White Light Endoscopy
White Light Endoscopy
Device: White light Endoscopy
White light Endoscopy

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 chromo-endoscopy has been shown to improve detection of flat adenomas [3]. 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 [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 [4].

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

Inclusion Criteria:

  1. Asymptomatic subjects undergoing screening colonoscopy
  2. age > 40
  3. average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma
  4. no colonoscopy in past 5 years
  5. ability to provide a written consent to trial participation

Exclusion Criteria:

  1. Patient age < 50
  2. Patients with prior colorectal surgery
  3. Pregnant or lactating women
  4. Colonoscopy done within the past 5 years
  5. Lack of consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422577

Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: James YW LAU, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01422577     History of Changes
Other Study ID Numbers: B-NBI
Study First Received: August 2, 2011
Last Updated: March 7, 2013
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on April 15, 2014