RCT: WLE vs. NBI in Upper Gastrointestinal Endoscopy
A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in Subjects Undergoing Upper Gastrointestinal Endoscopy
1 other identifier
interventional
600
1 country
1
Brief Summary
It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early gastric cancer. This could conceivably be due to the fact that these lesions may only present as subtle mucosal changes on conventional white light endoscopy (WLE) and thus be easily missed. In narrow band imaging (NBI) a rotating interference narrow band filter is interposed after the xenon light source such that when the NBI mode is switched on, discrete blue and green wavelengths are used and this improves mucosal surface contrast and facilitates visualization of mucosal details. A new NBI system is available that allows brighter illumination. We hypothesize that bright -NBI is superior to WLE in detecting focal gastric lesions such as gastric intestinal metaplasia, dysplasia and early gastric cancer in subjects undergoing gastroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 26, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 26, 2015
September 1, 2013
2.9 years
August 26, 2013
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection rate of intestinal metaplasia
Detection rate of intestinal metaplasia by white light endoscopy and by narrow band imaging
At the point of gastroscopy
Secondary Outcomes (1)
Aggregate detection rate of focal gastric lesions
At completion of gastroscopy
Study Arms (2)
white light endoscopy
NO INTERVENTIONwhite light endoscopy
narrow band imaging
ACTIVE COMPARATORnarrow band imaging
Interventions
Eligibility Criteria
You may qualify if:
- Subjects aged \> 50 years undergoing diagnostic or screening upper GI endoscopy
- ability to provide a written consent to trial participation.
You may not qualify if:
- presence of active gastrointestinal bleeding
- presence of coagulopathy precluding biopsies
- absence of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changi General Hospital
Singapore, Singapore, 529889, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiing Leong Ang, MBBS, MRCP
Changi General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2013
First Posted
September 18, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 26, 2015
Record last verified: 2013-09