Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms in Western countries. Whether such "treating instead of testing" strategy should be applied in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains uninvestigated.
Gastroesophageal Reflux Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease|
- Pre-defined significant upper digestive endoscopic findings [ Time Frame: within one month after the endoscopy examination ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Patients with pre-defined alarm symptoms
Patients without pre-defined alarm symptoms
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730106
|Lotung Poh-Ai Hospital|
|Lotung Town, Ilan County, Taiwan, 265|
|Principal Investigator:||Yao-Chun Hsu, M.D.||Lotung Poh-Ai Hospital|