Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT02728193
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2016-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Treatments of Very-early Stage Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '3 years', 'description': 'Hepatocellular Carcinoma will recurrence in 3 years'}, {'measure': 'Death', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['treatments', 'hepatocellular carcinoma'], 'conditions': ['Hepatocellular Carcinoma', 'Very-early Stage']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma\n2. Tumor diameter\\<2cm\n3. Child-Pugh class A liver function\n4. Without major organ dysfunction\n5. male or female patients \\> 18 years and \\<=70 years of age\n6. Voluntary participation in this clinical trial\n\nExclusion Criteria:\n\n1. Other anticancer treatment before therapy\n2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer\n3. Patients with other diseases that may affect the treatment of this treatment\n4. History of other malignant tumors\n5. Patients who are participating in other clinical trials\n6. Pregnant, lactating women'}, 'identificationModule': {'nctId': 'NCT02728193', 'briefTitle': 'Standard Treatments of Very-early Stage Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2012ZX10002016003001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA', 'description': 'Radiofrequency ablation', 'interventionNames': ['Procedure: RFA']}, {'type': 'EXPERIMENTAL', 'label': 'MWV', 'description': 'Microwave ablation', 'interventionNames': ['Procedure: MWV']}, {'type': 'EXPERIMENTAL', 'label': 'PEI', 'description': 'Percutaneous ethanol injection', 'interventionNames': ['Procedure: PEI']}], 'interventions': [{'name': 'RFA', 'type': 'PROCEDURE', 'armGroupLabels': ['RFA']}, {'name': 'MWV', 'type': 'PROCEDURE', 'otherNames': ['Microwave ablation'], 'armGroupLabels': ['MWV']}, {'name': 'PEI', 'type': 'PROCEDURE', 'description': 'Percutaneous ethanol injection', 'armGroupLabels': ['PEI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eastern hepatobilliary surgery hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president of the Eastern Hepatobiliary Surgery Hospotal', 'investigatorFullName': 'ShenFeng', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}}