RCT: WLE vs. NBI in Upper Gastrointestinal Endoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Changi General Hospital
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01945177
First received: August 26, 2013
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Gastric Intestinal Metaplasia
Gastric Cancer
Device: narrow band imaging
Device: white light endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in Subjects Undergoing Upper Gastrointestinal Endoscopy

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • Detection rate of intestinal metaplasia [ Time Frame: At the point of gastroscopy ] [ Designated as safety issue: No ]
    Detection rate of intestinal metaplasia by white light endoscopy and by narrow band imaging


Secondary Outcome Measures:
  • Aggregate detection rate of focal gastric lesions [ Time Frame: At completion of gastroscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 464
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: white light endoscopy
white light endoscopy
Active Comparator: narrow band imaging
narrow band imaging
Device: narrow band imaging
narrow band imaging
Device: white light endoscopy
white light endoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged > 50 years undergoing diagnostic or screening upper GI endoscopy
  2. ability to provide a written consent to trial participation.

Exclusion Criteria:

  1. presence of active gastrointestinal bleeding
  2. presence of coagulopathy precluding biopsies
  3. absence of informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945177

Contacts
Contact: Tiing Leong Ang, MBBS, MRCP +6568503558 tiing_leong_ang@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Tiing Leong Ang, MBBS, MRCP    +6568503558    tiing_leong_ang@cgh.com.sg   
Principal Investigator: Tiing Leong Ang, MBBS, MRCP         
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Tiing Leong Ang, MBBS, MRCP Changi General Hospital, Singapore
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01945177     History of Changes
Other Study ID Numbers: 2011/796/E
Study First Received: August 26, 2013
Last Updated: September 22, 2013
Health Authority: Singapore: Institutional Review Board

Keywords provided by Changi General Hospital:
endoscopy
gastric intestinal metaplasia
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Metaplasia
Gastritis, Atrophic
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes
Gastritis
Gastroenteritis

ClinicalTrials.gov processed this record on August 25, 2014