Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-28 @ 7:58 AM
Study NCT ID:
NCT05551832
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2022-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal ulcer incidence', 'timeFrame': 'Time Frame: during first 6 months after surgery', 'description': 'Number of Participants occurs Endoscopic visualization of presence or absence of marginal ulcers'}], 'secondaryOutcomes': [{'measure': 'QOL', 'timeFrame': 'Time Frame: during first 6 months after surgery', 'description': 'Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancretic Dissease (Benign/Malignancy)', 'BIle Duct Diseae(Benign/Malignancy)', 'Ampulla of Vater Disease (Benign/Malignancy)']}, 'descriptionModule': {'briefSummary': 'This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test\n\nExclusion Criteria:\n\n\\- Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX'}, 'identificationModule': {'nctId': 'NCT05551832', 'briefTitle': 'Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '3-2022-0193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months', 'description': 'Placebo beginning day of hospital discharge following PPPD for 6 months', 'interventionNames': ['Drug: Arm I (Placebo),']}, {'type': 'EXPERIMENTAL', 'label': 'Esmesol 40mg after PPPD for 6 months', 'description': 'Esmesol 40mg beginning day of hospital discharge following PPPD for 6 months', 'interventionNames': ['Drug: Arm II (ESMESOL)']}], 'interventions': [{'name': 'Arm I (Placebo),', 'type': 'DRUG', 'description': 'Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months', 'armGroupLabels': ['Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months']}, {'name': 'Arm II (ESMESOL)', 'type': 'DRUG', 'description': 'SMESOL 40 mg dose administrea daily at bedtime for 6 months after PPPD ,', 'armGroupLabels': ['Esmesol 40mg after PPPD for 6 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JoonSeong Park', 'role': 'CONTACT', 'email': 'JSPARK330@yuhs.ac', 'phone': '82-2-2019-3375'}], 'facility': 'GangnamSeverance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JoonSeong Park', 'role': 'CONTACT', 'email': 'JSPARK330@yuhs.ac', 'phone': '82-2-2019-3375'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Joon Seong Park', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}