Clinical trial NCT00730106: Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
Official title: Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Alarm symptoms
Gastrointestinal endoscopy
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult outpatients with characteristic GERD symptoms, in a district general 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.

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 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

Primary outcomes:
measure: Pre-defined significant upper digestive endoscopic findings
timeFrame: within one month after the endoscopy examination
Secondary outcomes:
Other outcomes:
Locations:
city: Lotung Town, Ilan County
country: Taiwan
facility: Lotung Poh-Ai Hospital
Study officials:
affiliation: Lotung Poh-Ai Hospital
name: Yao-Chun Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: