Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
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|ClinicalTrials.gov Identifier: NCT00730106|
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : October 19, 2010
|Condition or disease|
|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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||December 2009|
Patients with pre-defined alarm symptoms
Patients without pre-defined alarm symptoms
- Pre-defined significant upper digestive endoscopic findings [ Time Frame: within one month after the endoscopy examination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730106
|Lotung Poh-Ai Hospital|
|Lotung Town, Ilan County, Taiwan, 265|
|Principal Investigator:||Yao-Chun Hsu, M.D.||Lotung Poh-Ai Hospital|