Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-04-12 @ 11:01 AM
Study NCT ID:
NCT01434992
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2011-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Gastric mucosa for detecting Helicobacter pylori'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2011-09-14', 'studyFirstSubmitQcDate': '2011-09-14', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis accuracy for predicting of Helicobacter pylori infection status', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Assessment of the clinicopathologic factors related to correct diagnosis', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Helicobacter-associated Gastritis']}, 'referencesModule': {'references': [{'pmid': '8608753', 'type': 'BACKGROUND', 'citation': 'Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6. doi: 10.1055/s-2007-1005764.'}, {'pmid': '14606018', 'type': 'BACKGROUND', 'citation': 'Redeen S, Petersson F, Jonsson KA, Borch K. Relationship of gastroscopic features to histological findings in gastritis and Helicobacter pylori infection in a general population sample. Endoscopy. 2003 Nov;35(11):946-50. doi: 10.1055/s-2003-43479.'}, {'pmid': '10352086', 'type': 'BACKGROUND', 'citation': 'Mihara M, Haruma K, Kamada T, Komoto K, Yoshihara M, Sumii K, Kajiyama G. The role of endoscopic findings for the diagnosis of Helicobacter pylori infection: evaluation in a country with high prevalence of atrophic gastritis. Helicobacter. 1999 Mar;4(1):40-8. doi: 10.1046/j.1523-5378.1999.09016.x.'}, {'pmid': '23189930', 'type': 'DERIVED', 'citation': 'Cho JH, Chang YW, Jang JY, Shim JJ, Lee CK, Dong SH, Kim HJ, Kim BH, Lee TH, Cho JY. Close observation of gastric mucosal pattern by standard endoscopy can predict Helicobacter pylori infection status. J Gastroenterol Hepatol. 2013 Feb;28(2):279-84. doi: 10.1111/jgh.12046.'}]}, 'descriptionModule': {'briefSummary': 'Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.', 'detailedDescription': 'Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent upper endoscopy in the Kyung Hee University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent upper endoscopy\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 70\n* Severe systemic disease or advanced chronic liver disease\n* Medication history of NSAID, PPI, H2 blockers or antibiotics\n* History of H. pylori eradication therapy\n* History of gastric surgery\n* Recent history of upper GI bleeding\n* Gastric or duodenal ulcer (including old scar change) during endoscopy\n* Anemia (Hemoglobin level \\< 10mg/dL)\n* Pangastritis'}, 'identificationModule': {'nctId': 'NCT01434992', 'briefTitle': 'Detection of Helicobacter Pylori Infection by High Resolution Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus', 'orgStudyIdInfo': {'id': 'KHU-HP-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'H. pylori gastritis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun-Hyung Cho, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical and research fellow', 'investigatorFullName': 'Jun-Hyung Cho', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}