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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730106
• Other study ID #: OMCP-97-017
• Status: Completed
• Phase: N/A
• First received: August 4, 2008
• Last updated: October 18, 2010
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2010
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai Hospital	Lotung Town, Ilan County

Sponsors (1)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-defined significant upper digestive endoscopic findings		within one month after the endoscopy examination	No