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

Primary Purpose

Colonic Adenomas

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bright Narrow Band Imaging
White light Endoscopy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Adenomas

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bright Narrow Band Imaging

White Light Endoscopy

Arm Description

Bright Narrow Band Imaging

White Light Endoscopy

Outcomes

Primary Outcome Measures

Colorectal adenoma detection rate
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).
compare the advanced neoplasm detection rate
2. Sensitivity and specificity of either image modality in the diagnosis of malignant adenomas using pathology
compare the sensitivity and specificity between B-NBI and conventional colonoscopy

Full Information

First Posted
August 2, 2011
Last Updated
August 10, 2015
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01422577
Brief Title
Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenomas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1006 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright Narrow Band Imaging
Arm Type
Active Comparator
Arm Description
Bright Narrow Band Imaging
Arm Title
White Light Endoscopy
Arm Type
Active Comparator
Arm Description
White Light Endoscopy
Intervention Type
Device
Intervention Name(s)
Bright Narrow Band Imaging
Intervention Description
It is a High Definition system with narrow band imaging option in th endoscope.
Intervention Type
Device
Intervention Name(s)
White light Endoscopy
Intervention Description
White light Endoscopy
Primary Outcome Measure Information:
Title
Colorectal adenoma detection rate
Description
compare the rate in colorectal adenoma detection between B-NBI and conventional colonoscopy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
1. Rate in the detection of advanced neoplasms (defined by adenomas >10 mm in size, with high grade dysplasia or with >25% villous features).
Description
compare the advanced neoplasm detection rate
Time Frame
2 years
Title
2. Sensitivity and specificity of either image modality in the diagnosis of malignant adenomas using pathology
Description
compare the sensitivity and specificity between B-NBI and conventional colonoscopy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James YW LAU, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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

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