Evaluation of the Use of Confocal Endomicroscopy in Conjunction With Chromoendoscopy in the Detection of Gastric Preneoplastic Neoplasia and Neoplasia in a High-Risk Population (R-CE-GCEP)
This is a prospective randomised study investigating the use of chromoendoscopy and confocal
laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of
gastric cancer. Patients are randomised to undergo upper endoscopy using either confocal
laser endomicroscopy or standard whitelight endoscopy to investigate for gastric
preneoplastic and neoplastic lesions.Results are compared to histopathologic diagnosis made
on biopsies obtained during endoscopy.
Observational
Time Perspective: Prospective
Diagnostic yield
The diagnostic yield, number of tissue biopsies per patient and percentage of missed lesions for CLE arm will be obtained by analyzing as though only targeted tissue biopsies are taken (CLE-TB), meaning that tissue biopsy is considered to have been performed only if the endoscopist gave the CLE diagnosis of GIM, dysplasia or malignancy. If the CLE diagnosis is normal, targeted tissue biopsy will be analyzed as not having been taken, and the corresponding histology for that site is for documenting any misdiagnosis by CLE in this study.
On histopathologic diagnosis, usually 1-2 days after endoscopy
No
Khay Guan Yeoh, MBBS; M Med
Principal Investigator
National University Health System
Singapore: Domain Specific Review Boards
NMRC/TCR/001/2007/CLE
NCT01384201
August 2007
October 2010
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