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

NCT ID: NCT00730106

Last Updated: 2010-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Patients with pre-defined alarm symptoms

No interventions assigned to this group

2

Patients without pre-defined alarm symptoms

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lotung Poh-Ai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lotung Poh-Ai hospital

Principal Investigators

Yao-Chun Hsu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lotung Poh-Ai Hospital

Locations

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, , Taiwan

Countries

Taiwan

Other Identifiers

OMCP-97-017

Identifier Type: -

Identifier Source: org_study_id