Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1177 participants
OBSERVATIONAL
2003-01-31
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GI observation
Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Dysphagia
* Gastrointestinal bleeding
* Gastrointestinal malignancy
* Recent EGD (in the past 5 years)
18 Years
ALL
Yes
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
Midwest Biomedical Research Foundation
OTHER
Responsible Party
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PRATEEK SHARMA
Principal Investigator
Principal Investigators
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Prateek Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Veterans Affairs Medical Center of Kansas City
Locations
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Department of Veterans Affairs Medical Center
Kansas City, Missouri, United States
Countries
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References
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Earlam RJ, Amerigo J, Kakavoulis T, Pollock DJ. Histological appearances of oesophagus, antrum and duodenum and their correlation with symptoms in patients with a duodenal ulcer. Gut. 1985 Jan;26(1):95-100. doi: 10.1136/gut.26.1.95.
Goldman MS Jr, Rasch JR, Wiltsie DS, Finkel M. The incidence of esophagitis in peptic ulcer disease. Am J Dig Dis. 1967 Oct;12(10):994-9. doi: 10.1007/BF02233258. No abstract available.
Sonnenberg A, El-Serag HB. Clinical epidemiology and natural history of gastroesophageal reflux disease. Yale J Biol Med. 1999 Mar-Jun;72(2-3):81-92.
Winters C Jr, Spurling TJ, Chobanian SJ, Curtis DJ, Esposito RL, Hacker JF 3rd, Johnson DA, Cruess DF, Cotelingam JD, Gurney MS, et al. Barrett's esophagus. A prevalent, occult complication of gastroesophageal reflux disease. Gastroenterology. 1987 Jan;92(1):118-24.
Johnston MH, Hammond AS, Laskin W, Jones DM. The prevalence and clinical characteristics of short segments of specialized intestinal metaplasia in the distal esophagus on routine endoscopy. Am J Gastroenterol. 1996 Aug;91(8):1507-11.
Hirota WK, Loughney TM, Lazas DJ, Maydonovitch CL, Rholl V, Wong RK. Specialized intestinal metaplasia, dysplasia, and cancer of the esophagus and esophagogastric junction: prevalence and clinical data. Gastroenterology. 1999 Feb;116(2):277-85. doi: 10.1016/s0016-5085(99)70123-x.
Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. doi: 10.3109/00365529109109532.
Jones R, Lydeard S. Dyspepsia in the community: a follow-up study. Br J Clin Pract. 1992 Summer;46(2):95-7.
Voutilainen M, Sipponen P, Mecklin JP, Juhola M, Farkkila M. Gastroesophageal reflux disease: prevalence, clinical, endoscopic and histopathological findings in 1,128 consecutive patients referred for endoscopy due to dyspeptic and reflux symptoms. Digestion. 2000;61(1):6-13. doi: 10.1159/000007730.
de Moraes-Filho JP, Zaterka S, Pinotti HW, Bettarello A. Esophagitis and duodenal ulcer. Digestion. 1974;11(5-6):338-46. doi: 10.1159/000197601. No abstract available.
de Moraes-Filho JP. Lack of specificity of the acid perfusion test in duodenal ulcer patients. Am J Dig Dis. 1974 Sep;19(9):785-90. doi: 10.1007/BF01071936. No abstract available.
Flook D, Stoddard CJ. Gastro-oesophageal reflux and oesophagitis before and after vagotomy for duodenal ulcer. Br J Surg. 1985 Oct;72(10):804-7. doi: 10.1002/bjs.1800721010.
Other Identifiers
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PS0014
Identifier Type: -
Identifier Source: org_study_id
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