Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT03577067
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2018-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Complicated Outcome Prediction After Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal resistive index (RRI)', 'timeFrame': 'up to 7 days after surgery', 'description': 'the association between RRI and occurrence of hepatic complications during the first postoperative week.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Neoplasms']}, 'descriptionModule': {'briefSummary': 'Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients resectable and affected by primary and secondary liver disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients resectable and affected by primary and secondary liver disease\n\nExclusion Criteria:\n\nSubjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.'}, 'identificationModule': {'nctId': 'NCT03577067', 'briefTitle': 'Complicated Outcome Prediction After Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index', 'orgStudyIdInfo': {'id': 'CE Humanitas 100/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients submitted to liver resection', 'description': 'Patients underwent liver resection for primary and secondary disease', 'interventionNames': ['Procedure: Liver resection for primary and secondary disease']}], 'interventions': [{'name': 'Liver resection for primary and secondary disease', 'type': 'PROCEDURE', 'description': 'Liver resection in parenchyma-sparing setting for primary and secondary disease', 'armGroupLabels': ['Patients submitted to liver resection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FACS', 'investigatorFullName': 'Prof. Guido Torzilli', 'investigatorAffiliation': 'Humanitas Clinical and Research Center'}}}}