Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 6:40 PM
Study NCT ID:
NCT00730106
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2008-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-18', 'studyFirstSubmitDate': '2008-08-04', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-defined significant upper digestive endoscopic findings', 'timeFrame': 'within one month after the endoscopy examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastroesophageal reflux disease', 'Alarm symptoms', 'Gastrointestinal endoscopy'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms in Western countries. Whether such "treating instead of testing" strategy should be applied in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains uninvestigated.', 'detailedDescription': 'This study amis to investigate upper endoscopic findings of typical acid reflux patients with and without alarm symptoms in Taiwan During the period from May 2008 to December 2009, consecutive adult outpatients, who receive upper endoscopy for characteristic reflux symptoms of heartburn or acid regurgitation, are invited to participate. All study participants are evaluated for presence of pre-defined alarm symptoms including odynophagia or dysphagia, gastrointestinal bleeding, involuntary body weight loss and anemia.\n\nUpper endoscopic procedures are performed with standard electronic videoendoscope (GIF-Q240 or GIF-Q260; Olympus, Tokyo, Japan) by experienced endoscopists; each of them had previously performed a minimum of 2,000 upper endoscopy exams. Representative images are taken and stored as electronic files in a digital image system for later analysis.\n\nThe following five significant endoscopic findings are pre-defined endpoints of this study: 1) any malignant lesion in the upper digestive tract, 2) Barrett esophagus, 3) severe erosive esophagitis (LA grade C or D), 4) peptic stricture, 5) peptic ulcer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult outpatients with characteristic GERD symptoms, in a district general hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* outpatients\n* chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation), evaluated by standard questionnaire\n* undergo upper digestive endoscopy\n\nExclusion Criteria:\n\n* age less than 18 years old or more than 90 years old\n* unable to complete upper endoscopy\n* known diagnosis of gastroesophageal malignancy\n* follow-up visit for known gastroesophageal lesion identified by previous upper endoscopy\n* failure to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT00730106', 'briefTitle': 'Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Lotung Poh-Ai Hospital'}, 'officialTitle': 'Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'OMCP-97-017'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with pre-defined alarm symptoms'}, {'label': '2', 'description': 'Patients without pre-defined alarm symptoms'}]}, 'contactsLocationsModule': {'locations': [{'zip': '265', 'city': 'Lotung Town, Ilan County', 'country': 'Taiwan', 'facility': 'Lotung Poh-Ai Hospital'}], 'overallOfficials': [{'name': 'Yao-Chun Hsu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lotung Poh-Ai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lotung Poh-Ai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hsing-Hong Chen/Superintendent', 'oldOrganization': 'Lotung Poh-Ai hospital'}}}}