Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-01 @ 1:08 AM
Study NCT ID:
NCT01256034
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2010-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'k-furukawa@umin.ac.jp', 'phone': '+81-43-226-2269', 'title': 'Dr. Katsunori Furukawa', 'organization': 'Chiba University Graduate School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'preoperative immunonutrition', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'ordinary diet', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Infectious Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'preoperative immunonutrition'}, {'id': 'OG001', 'title': 'Group B', 'description': 'ordinary diet'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma IL-6, CRP, Th1/Th2 Balance', 'timeFrame': '14 days', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'preoperative immunonutrition'}, {'id': 'FG001', 'title': 'Group B', 'description': 'ordinary diet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'preoperative immunonutrition'}, {'id': 'BG001', 'title': 'Group B', 'description': 'ordinary diet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '65.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-24', 'studyFirstSubmitDate': '2010-12-07', 'resultsFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-24', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Infectious Complication', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Plasma IL-6, CRP, Th1/Th2 Balance', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunonutrition', 'pancreaticoduodenectomy', 'Th1', 'Th2'], 'conditions': ['Pancreatic Cancer', 'Bile Duct Cancer']}, 'referencesModule': {'references': [{'pmid': '24589090', 'type': 'DERIVED', 'citation': 'Aida T, Furukawa K, Suzuki D, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Preoperative immunonutrition decreases postoperative complications by modulating prostaglandin E2 production and T-cell differentiation in patients undergoing pancreatoduodenectomy. Surgery. 2014 Jan;155(1):124-33. doi: 10.1016/j.surg.2013.05.040. Epub 2013 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.', 'detailedDescription': 'The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.\n\nObject of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients underwent pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* age younger than 18 years\n* ongoing infection\n* gastrointestinal obstruction\n* respiratory dysfunction\n* cardiac dysfunction\n* hepatic dysfunction\n* renal failure\n* history of recent immunosuppressive or immunological diseases\n* preoperative evidence of widespread metastatic disease'}, 'identificationModule': {'nctId': 'NCT01256034', 'acronym': 'EPIPD', 'briefTitle': 'Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Chiba University'}, 'officialTitle': 'Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'furukawa2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'preoperative immunonutrition', 'interventionNames': ['Dietary Supplement: Oral IMPACT']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'ordinary diet'}], 'interventions': [{'name': 'Oral IMPACT', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan'], 'description': 'oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8670', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}], 'overallOfficials': [{'name': 'Katsunori Furukawa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chiba University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiba University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Katsunori Furukawa', 'investigatorAffiliation': 'Chiba University'}}}}