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

18 Years
90 Years
Not Enrolling
Gastroesophageal Reflux Disease

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Trial Information

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.

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

- failure to obtain informed consent

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Pre-defined significant upper digestive endoscopic findings

Outcome Time Frame:

within one month after the endoscopy examination

Safety Issue:


Principal Investigator

Yao-Chun Hsu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lotung Poh-Ai Hospital


Taiwan: Department of Health

Study ID:




Start Date:

May 2008

Completion Date:

December 2009

Related Keywords:

  • Gastroesophageal Reflux Disease
  • Gastroesophageal reflux disease
  • Alarm symptoms
  • Gastrointestinal endoscopy
  • Gastroesophageal Reflux