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

This study has been completed.
Sponsor:
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00730106
First received: August 4, 2008
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

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
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • Pre-defined significant upper digestive endoscopic findings [ Time Frame: within one month after the endoscopy examination ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with pre-defined alarm symptoms
2
Patients without pre-defined alarm symptoms

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult outpatients with characteristic GERD symptoms, in a district general hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730106

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

No publications provided

Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital
ClinicalTrials.gov Identifier: NCT00730106     History of Changes
Other Study ID Numbers: OMCP-97-017
Study First Received: August 4, 2008
Last Updated: October 18, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on April 14, 2014