Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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 |
Inclusion Criteria:
- Asymptomatic subjects undergoing screening colonoscopy
- age > 40
- 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
- no colonoscopy in past 5 years
- ability to provide a written consent to trial participation
Exclusion Criteria:
- Patient age < 50
- Patients with prior colorectal surgery
- Pregnant or lactating women
- Colonoscopy done within the past 5 years
- Lack of consent
Contacts and Locations 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 May 16, 2013