Demographics and Findings of Upper Endoscopy Patients
|Study Design:||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|
- Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576992
|Contact: April D Higbee, RN, BSN||816-861-4700 ext firstname.lastname@example.org|
|United States, Missouri|
|Department of Veterans Affairs Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Sub-Investigator: Ajay Bansal, MD|
|Sub-Investigator: Amit Rastogi, MD|
|Principal Investigator: Prateek Sharma, MD|
|Principal Investigator:||Prateek Sharma, MD||Department of Veterans Affairs Medical Center of Kansas City|