Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 10:40 AM
Study NCT ID:
NCT05257434
Status:
RECRUITING
Last Update Posted:
2022-02-25
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term outcomes', 'timeFrame': '5year', 'description': 'overall survival rate'}], 'secondaryOutcomes': [{'measure': 'short-term outcomes', 'timeFrame': 'up to 24 weeks', 'description': 'postoperative complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '37380749', 'type': 'DERIVED', 'citation': 'Kimura J, Sui K, Tabuchi M, Sakamoto S, Murokawa T, Iwata J, Morita S, Iiyama T, Okabayashi T. Preoperative percent body fat in bioelectrical impedance analysis predicts pancreatic fistula after pancreaticoduodenectomy. Langenbecks Arch Surg. 2023 Jun 28;408(1):248. doi: 10.1007/s00423-023-02998-y.'}]}, 'descriptionModule': {'briefSummary': 'postoperative outcomes were evaluated by using inBody test', 'detailedDescription': 'postoperative outcomes were evaluated by using inBody test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'surgically treated patients who were suffering from hepato-biliary-pancreatic cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgically treated patients\n\nExclusion Criteria:\n\n* a body weight loss of \\>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease'}, 'identificationModule': {'nctId': 'NCT05257434', 'briefTitle': 'Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test', 'organization': {'class': 'OTHER', 'fullName': 'Kochi University'}, 'officialTitle': 'Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test', 'orgStudyIdInfo': {'id': 'Point study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inbody', 'type': 'BEHAVIORAL', 'description': 'Body fluid composition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '781-8555', 'city': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takehiro Okabayashi', 'role': 'CONTACT', 'email': 'tokabaya@gmail.com', 'phone': '+81- 88-837-3000'}], 'facility': 'Takehiro Okabayashi', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kochi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Gastroenterological Surgery', 'investigatorFullName': 'Takehiro Okabayashi', 'investigatorAffiliation': 'Kochi University'}}}}