Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Demographics and Findings of Upper Endoscopy Patients
This study is currently recruiting participants.
Verified by Kansas City Veteran Affairs Medical Center, April 2008
Sponsored by: Kansas City Veteran Affairs Medical Center
Information provided by: Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00576992
  Purpose

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
Barrett Esophagus
Gastroesophageal Reflux

MedlinePlus related topics: Endoscopy Esophagus Disorders GERD Hernia Hiatal Hernia Indigestion
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms

Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:
  • Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms [ Time Frame: prospectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses [ Time Frame: prospectively ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 3000
Study Start Date: January 2003
Estimated Study Completion Date: January 2013
Groups/Cohorts
GI observation
Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576992

Contacts
Contact: April D Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov

Locations
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            
Sub-Investigator: Sachin Wani, MD            
Sub-Investigator: Rashmi Tadiparthi, MD            
Principal Investigator: Prateek Sharma, MD            
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
  More Information

Publications:
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. Review.
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.
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.
Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. Review.
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, Färkkilä 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.
de Moraes-Filho JP, Zaterka S, Pinotti HW, Bettarello A. Esophagitis and duodenal ulcer. Digestion. 1974;11(5-6):338-46. 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. No abstract available.
Flook D, Stoddard CJ. Gastroesophageal reflux and esophagitis before and after vagotomy for duodenal ulcer. Br J Surg 1985; 72: 804-7
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.
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. No abstract available.

Responsible Party: Midwest Biomedical Research Foundation ( Prateek Sharma, MD )
Study ID Numbers: PS0014
Study First Received: December 18, 2007
Last Updated: April 11, 2008
ClinicalTrials.gov Identifier: NCT00576992  
Health Authority: United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:
Barrett's Esophagus
Demographics
Questionnaire
Heartburn

Study placed in the following topic categories:
Pyrosis
Esophageal disorder
Abdominal Pain
Gastrointestinal Diseases
Pain
Dyspepsia
Gastroesophageal Reflux
Deglutition Disorders
Esophageal Motility Disorders
Signs and Symptoms
Digestive System Abnormalities
Digestive System Diseases
Heartburn
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009