Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 6:42 AM
Study NCT ID:
NCT03065868
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2017-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562464', 'term': 'Polyposis, Gastric'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open labelled randomized controlled trial. randomization : 2015 September'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2017-02-18', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare regression rate of gastric polyps between H. pylori eradication and non-eradication groups. Regression of gastric polyp: one of below 1) Disappearance of gastric polyp 2) Reduction of polyp size over 50%', 'timeFrame': 'up to 24months', 'description': 'Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp\n\nStudy group\n\n1. H. pylori eradication\n2. H. pylori non-eradication\n\nDefinition of gastric polyp change:\n\n1. Disappearance of gastric polyp\n2. Reduction of polyp size over 50%\n3. No change of size or increased size'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric polyp', 'Helicobacter pylori eradication'], 'conditions': ['Gastric Polyp', 'Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '31974914', 'type': 'DERIVED', 'citation': 'Nam SY, Lee SW, Jeon SW, Kwon YH, Lee HS. Helicobacter pylori Eradication Regressed Gastric Hyperplastic Polyp: A Randomized Controlled Trial. Dig Dis Sci. 2020 Dec;65(12):3652-3659. doi: 10.1007/s10620-020-06065-0. Epub 2020 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial)\n\n1. Study design: open labeled RCT\n2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)\n3. Treatment plan\n\n 1. Baseline EGD\n\n : 0.3-1cm sized polyp - bx \\& CLO test (antrum \\& body)\n\n ==\\> if H. pylori positive and eligible patients, randomization\n 2. Triple therapy\n 3. UBT (4week after eradication)\n 4. Follow-up EGD: gross finding, CLO test\n4. Evaluation of polyp regression\n\n 1. disappear\n 2. regression over 50% (size, number)\n 3. no change or increase (size, number)', 'detailedDescription': '(A) Study population\n\n1. inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr\n2. exclusion peptic ulcer, healing stage or acute stage recent use of PPI within 4weeks Liver cirrhosis, renal insufficiency, other serious chronic or acute disease current infection of other bacteria, virus, or fungus cancer, psychologic disease heavy drinker drug abuser pregnant women, Penicillin allergy, digoxin, antifungal, wafarin previosu H. pylori eradication enroll gastric polyp with bleeding or malignant transformation tiny polyp less than 3mm.\n\n(B) Study method\n\n1. Study design: open labeled RCT\n2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)\n3. Treatment plan\n\n 1. Baseline EGD: 0.3-1cm sized polyp - bx \\& CLO test (antrum \\& body) ==\\> if H. pylori positive and eligible patients, randomization\n 2. Triple therapy\n 3. UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication)\n 4. Follow-up EGD (3-9M): gross finding, CLO test\n4. Evaluation of polyp regression\n\n 1. disappear\n 2. regression over 50% (size, number)\n 3. no change or increase (size, number)\n5. Statistical analysis\n\n 1. Chi-square test to compare polyp regression between treatment \\& control group.\n 2. t-test to compare continuous variables between treatment \\& control group.\n 3. Paired T-test to compare the size between baseline and follow-up EGD.\n 4. Regression analysis: univariate \\& multivariate analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastric polyp with current infection of H. pylori\n* Gastric polyp size with 3mm-10mm\n* Age of 20 yr - 70yr\n\nExclusion Criteria:\n\n* Gastric ulcer ir duodenal ulcer (healing stage or acute stage)\n* Use of PPI within 4weeks\n* Liver cirrhosis, renal insufficiency, other serious chronic or acute disease\n* Current infection of other bacteria, virus, or fungus\n* Any cancer, psychologic disease\n* Heavy drinker\n* Drug abuser\n* Pregnant women\n* Penicillin allergy\n* Use of digoxin, antifungal, wafarin\n* Previous H. pylori eradication\n* Gastric polyp with bleeding or malignant transformation\n* Tiny polyp less than 3mm.'}, 'identificationModule': {'nctId': 'NCT03065868', 'briefTitle': 'Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)', 'orgStudyIdInfo': {'id': 'KNUMC_15-1045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eradictaion', 'description': 'H. pylori eradication group', 'interventionNames': ['Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)']}, {'type': 'NO_INTERVENTION', 'label': 'non-eradication', 'description': 'H. pylori non-eradication group'}], 'interventions': [{'name': 'H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)', 'type': 'DRUG', 'otherNames': ['Triple Therapy'], 'description': 'H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment', 'armGroupLabels': ['eradictaion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Su Youn Nam', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Su Youn Y Nam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Su Youn Nam', 'investigatorAffiliation': 'Kyungpook National University Chilgok Hospital'}}}}