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Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms

Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00730106
Enrollment
1000
Registered
2008-08-08
Start date
2008-05-31
Completion date
2009-12-31
Last updated
2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease, Alarm symptoms, Gastrointestinal endoscopy

Brief summary

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.

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.

Interventions

None listed

Sponsors

Lotung Poh-Ai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pre-defined significant upper digestive endoscopic findingswithin one month after the endoscopy examination

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026