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

NCT01422577 | Completed

• 1 other identifier: B-NBI
• Study Type: interventional
• Target: 1,006
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Adenomas

Outcome Measures

Primary Outcomes (1)

• Colorectal adenoma detection rate

  compare the rate in colorectal adenoma detection between B-NBI and conventional colonoscopy

  2 years

Secondary Outcomes (2)

• 1. Rate in the detection of advanced neoplasms (defined by adenomas >10 mm in size, with high grade dysplasia or with >25% villous features).

  2 years

• 2. Sensitivity and specificity of either image modality in the diagnosis of malignant adenomas using pathology

  2 years

Study Arms (2)

Bright Narrow Band Imaging

ACTIVE COMPARATOR

Bright Narrow Band Imaging

Device: Bright Narrow Band Imaging

White Light Endoscopy

ACTIVE COMPARATOR

White Light Endoscopy

Device: White light Endoscopy

Interventions

Bright Narrow Band Imaging DEVICE

It is a High Definition system with narrow band imaging option in th endoscope.

Bright Narrow Band Imaging

White light Endoscopy DEVICE

White light Endoscopy

White Light Endoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient age \< 50
• Patients with prior colorectal surgery
• Pregnant or lactating women
• Colonoscopy done within the past 5 years
• Lack of consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Study Officials

• James YW LAU, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 24, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CN (1)