Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT01387061
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2011-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resection for Multiple Hepatocellular Carcinomas (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-18', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival plus multivariate analysis', 'timeFrame': '10 years', 'description': 'The primary endpoint of the study was the overall survival of patients resected for multiple HCC, and the univariate and multivariate analyses of prognostic factors for overall survival.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '10 years', 'description': 'The secondary endpoint was the disease-free survival.'}]}, 'conditionsModule': {'keywords': ['liver resection', 'hepatic resection', 'intraoperative ultrasound'], 'conditions': ['Hepatocellular Carcinoma', 'Multiple Tumors', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with multiple HCC without macrovascular invasion on liver cirrhosis\n\nExclusion Criteria:\n\n* macrovascular invasion;\n* normal liver;\n* distant or lymphnodes metastasis'}, 'identificationModule': {'nctId': 'NCT01387061', 'briefTitle': 'Resection for Multiple Hepatocellular Carcinomas (HCC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis', 'orgStudyIdInfo': {'id': 'multipleHCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hepatic resection', 'interventionNames': ['Procedure: hepatic resection']}], 'interventions': [{'name': 'hepatic resection', 'type': 'PROCEDURE', 'description': 'surgical resection of the liver for multiple HCC', 'armGroupLabels': ['hepatic resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano, Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'University of Milan IRCCS Istituto Clinico Humanitas'}], 'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Prof. Guido Torzilli', 'investigatorAffiliation': 'University of Milan'}}}}