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Demographics and Findings of Upper Endoscopy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576992
Recruitment Status : Terminated (Recruitment not being met)
First Posted : December 19, 2007
Last Update Posted : May 30, 2017
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation

Brief Summary:
The purpose of this study is to evaluate the demographics, patients symptoms, and findings during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy suite, will be asked to fill out questionnaires pertaining to their symptoms and indications for the procedure. This will be done before their procedure during the interview period preceding endoscopy. The patient's answers to this questionnaire will aid us in determining the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses.

Condition or disease
Barrett Esophagus Gastroesophageal Reflux

Detailed Description:

Barrett's esophagus is a pre-malignant condition associated with adenocarcinoma of the lower esophagus, and is found in 10-15% of patients with Gastroesophageal Reflux Disease (GERD). In prospective studies of patients undergoing endoscopy for reflux symptoms, the prevalence of long segments of Barrett's Esophagus (3cm or greater) is reported to be 3% and that of short segment Barrett's Esophagus (less than 3cm), to be approximately 7-8%. Early diagnosis with surveillance is considered the optimal approach in patients with Barrett's, given the poor survival of advanced adenocarcinoma of the esophagus. However, classic symptoms of GERD may be diminished in some patients with Barrett's esophagus, possibly leading to a lower incidence of endoscopy with early diagnosis.

Extraesophageal manifestations of GERD include hoarseness, wheezing, and globus sensation. Dyspepsia is defined as pain or discomfort centered in the upper abdomen. Some reports have quantified the incidence of dyspepsia as occurring in up to 40% of adults over a six-month period. The differential diagnosis of dyspepsia includes gastric or duodenal ulcer, gastroesophageal reflux disease, gastric cancer, and non-ulcer dyspepsia. The incidence of peptic ulcer disease appears to be decreasing in our population, largely due to the lower prevalence of Helicobacter pylori infection among the population. Thus, esophageal lesions are responsible for an increasing number of dyspeptic patients.

Controversies exist as to the proper management of patients presenting with dyspepsia. Empiric acid-suppression therapy is often the first step in the management of dyspeptic patients. Many physicians have adopted a test-and-treat strategy for Helicobacter pylori infection. Finally, upper endoscopy may be performed. This test is considered the gold standard for the diagnosis of esophageal and gastroduodenal lesions. The initial evaluation of dyspeptic patients may be modified by other factors in their presentation, i.e. age greater than 50 or the presence of alarm symptoms (weight loss, dysphagia, evidence of gastrointestinal bleeding, anemia, or previous gastric surgery).

A distinction between the various causes of dyspepsia is important to establish in view of the significant differences in treatment strategies. Several previously reported studies have established a correlation between dyspepsia, with or without peptic ulcer disease, and erosive esophagitis. These studies were limited by a high degree of patient selection and narrow patient populations. Although the prevalence of erosive esophagitis and Barrett's Esophagus has been reported in patients with typical GERD symptoms, i.e. heartburn and regurgitation, the exact prevalence in patients with atypical symptoms of GERD (cough, asthma, wheezing, dysphagia), abdominal pain and dyspepsia is not readily known, especially in a VA population. Given that these esophageal diseases affect mainly older Caucasian males, studying the prevalence of these diseases in a VA population would be of extreme significance and importance.

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Study Type : Observational
Actual Enrollment : 1177 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms
Study Start Date : January 2003
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

GI observation
Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.

Primary Outcome Measures :
  1. Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit

Inclusion Criteria:

  • Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper abdominal pain, anemia (patients referred by their primary care physicians with a diagnosis of low hemoglobin (< 10 G/DL, and or dyspepsia

Exclusion Criteria:

  • Weight loss (Weight loss of > 10% of their mean body weight over last 6 months)
  • Dysphagia
  • Gastrointestinal bleeding
  • Gastrointestinal malignancy
  • Recent EGD (in the past 5 years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576992

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United States, Missouri
Department of Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
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Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City


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Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation Identifier: NCT00576992    
Other Study ID Numbers: PS0014
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by PRATEEK SHARMA, Midwest Biomedical Research Foundation:
Barrett's Esophagus
Additional relevant MeSH terms:
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Barrett Esophagus
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Precancerous Conditions