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

Colonic Adenomas Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422577
• Other study ID #: B-NBI
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: August 10, 2015
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: March 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenomas

Intervention

Device:
• Bright Narrow Band Imaging
It is a High Definition system with narrow band imaging option in th endoscope.
• White light Endoscopy
White light Endoscopy

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal adenoma detection rate	compare the rate in colorectal adenoma detection between B-NBI and conventional colonoscopy	2 years	No
Secondary	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 years	No
Secondary	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	2 years	No