- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730106
Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Lotung Town, Ilan County, Taiwan, 265
- Lotung Poh-Ai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- outpatients
- chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation), evaluated by standard questionnaire
- undergo upper digestive endoscopy
Exclusion Criteria:
- age less than 18 years old or more than 90 years old
- unable to complete upper endoscopy
- known diagnosis of gastroesophageal malignancy
- follow-up visit for known gastroesophageal lesion identified by previous upper endoscopy
- failure to obtain informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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1
Patients with pre-defined alarm symptoms
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2
Patients without pre-defined alarm symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pre-defined significant upper digestive endoscopic findings
Time Frame: within one month after the endoscopy examination
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within one month after the endoscopy examination
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yao-Chun Hsu, M.D., Lotung Poh-Ai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMCP-97-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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