Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-02 @ 4:07 PM
Study NCT ID:
NCT00576992
Status:
TERMINATED
Last Update Posted:
2017-05-30
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Demographics and Findings of Upper Endoscopy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1177}}, 'statusModule': {'whyStopped': 'Recruitment not being met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Barrett's Esophagus", 'Demographics', 'Questionnaire', 'Heartburn'], 'conditions': ['Barrett Esophagus', 'Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '10780569', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3781178', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '8759651', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9922307', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1896825', 'type': 'BACKGROUND', 'citation': 'Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. doi: 10.3109/00365529109109532.'}, {'pmid': '1457318', 'type': 'BACKGROUND', 'citation': 'Jones R, Lydeard S. Dyspepsia in the community: a follow-up study. Br J Clin Pract. 1992 Summer;46(2):95-7.'}, {'pmid': '10671769', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4463131', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4852636', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4041712', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3965370', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6045993', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nExtraesophageal 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.\n\nControversies 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).\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Weight loss (Weight loss of \\> 10% of their mean body weight over last 6 months)\n* Dysphagia\n* Gastrointestinal bleeding\n* Gastrointestinal malignancy\n* Recent EGD (in the past 5 years)'}, 'identificationModule': {'nctId': 'NCT00576992', 'briefTitle': 'Demographics and Findings of Upper Endoscopy Patients', 'organization': {'class': 'OTHER', 'fullName': "Midwest Veterans' Biomedical Research Foundation"}, 'officialTitle': 'A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms', 'orgStudyIdInfo': {'id': 'PS0014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GI observation', 'description': 'Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Prateek Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Veterans Affairs Medical Center of Kansas City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Biomedical Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kansas City Veteran Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'PRATEEK SHARMA', 'investigatorAffiliation': 'Midwest Biomedical Research Foundation'}}}}