Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease
This study amis to investigate upper endoscopic findings of typical acid reflux patients
with and without alarm symptoms in Taiwan During the period from May 2008 to December 2009,
consecutive adult outpatients, who receive upper endoscopy for characteristic reflux
symptoms of heartburn or acid regurgitation, are invited to participate. All study
participants are evaluated for presence of pre-defined alarm symptoms including odynophagia
or dysphagia, gastrointestinal bleeding, involuntary body weight loss and anemia.
Upper endoscopic procedures are performed with standard electronic videoendoscope (GIF-Q240
or GIF-Q260; Olympus, Tokyo, Japan) by experienced endoscopists; each of them had previously
performed a minimum of 2,000 upper endoscopy exams. Representative images are taken and
stored as electronic files in a digital image system for later analysis.
The following five significant endoscopic findings are pre-defined endpoints of this study:
1) any malignant lesion in the upper digestive tract, 2) Barrett esophagus, 3) severe
erosive esophagitis (LA grade C or D), 4) peptic stricture, 5) peptic ulcer.
Observational
Observational Model: Cohort, Time Perspective: Cross-Sectional
Pre-defined significant upper digestive endoscopic findings
within one month after the endoscopy examination
No
Yao-Chun Hsu, M.D.
Principal Investigator
Lotung Poh-Ai Hospital
Taiwan: Department of Health
OMCP-97-017
NCT00730106
May 2008
December 2009
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