跳至主要内容
临床试验/NCT00576992
NCT00576992终止不适用

A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms

Midwest Biomedical Research Foundation1 个研究点 分布在 1 个国家目标入组 1,177 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1,177
试验地点
1
主要终点
Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms

时间窗: 1 year

次要结局

  • Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses(1 year)

研究者

发起方
Midwest Biomedical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

PRATEEK SHARMA

Principal Investigator

Midwest Biomedical Research Foundation

研究点 (1)

Loading locations...

相似试验