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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730106
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : October 19, 2010
Information provided by:
Lotung Poh-Ai Hospital

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.

Condition or disease
Gastroesophageal Reflux Disease

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 : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Patients with pre-defined alarm symptoms
Patients without pre-defined alarm symptoms

Primary Outcome Measures :
  1. Pre-defined significant upper digestive endoscopic findings [ Time Frame: within one month after the endoscopy examination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult outpatients with characteristic GERD symptoms, in a district general hospital

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00730106

Lotung Poh-Ai Hospital
Lotung Town, Ilan County, Taiwan, 265
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Principal Investigator: Yao-Chun Hsu, M.D. Lotung Poh-Ai Hospital

Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital Identifier: NCT00730106     History of Changes
Other Study ID Numbers: OMCP-97-017
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: October 2010

Keywords provided by Lotung Poh-Ai Hospital:
Gastroesophageal reflux disease
Alarm symptoms
Gastrointestinal endoscopy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases