A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy
Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible
for inclusion. WLE without magnification was performed first in eligible patients. Based on
an assessment of the shape (such as flat, depressed or elevated) and color (pale or
reddened), small focal gastric lesions were identified and included for evaluation by
experienced endoscopists. When such a lesion was detected during non-magnifying observation
with WLE, the mode was then changed to ME-NBI for observation of microvascular pattern and
ME-AIM for observation of microsurface pattern subsequently. All endoscopic images of the
whole procedure were recorded in digital filing system for later evaluation. To avoid
possible selection bias and to maintain the quality of the study, all images of each
endoscopic modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one
slide and displayed independently of the images of other endoscopic modality, were evaluated
by 4 skilled endoscopists, who were not access to the clinical and pathological data. The
general consensus was established for an assessment of each lesion. Two forceps biopsy
specimens were taken from each lesion and pathological diagnosis were used as the criterion
standard for cancer diagnosis.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM)
Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.
1 week
No
Xinghua Lu, Dr
Principal Investigator
Peking Union Medical College Hospital
China: Ministry of Health
LXH-EGC-1
NCT01617876
March 2010
March 2012
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