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Completed

NCT Number: NCT00730106

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, 265, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pre-defined significant upper digestive endoscopic findings

    Time frame: within one month after the endoscopy examination

Sponsors and collaborators

Lead sponsor

Lotung Poh-Ai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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