Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 9:52 AM
Study NCT ID:
NCT00825669
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2009-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2010'}], 'secondaryOutcomes': [{'measure': 'the changes of the PVTT', 'timeFrame': '2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'Portal vein tumor thrombus', 'laser ablation'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.', 'detailedDescription': 'Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might further increase the pressure of portal vein and lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings.\n2. The functions of the kidney, heart and lung and the routine test of the blood are in good condition.\n3. The liver function is of grade A or B in Child-Pugh classification.\n4. The patient is eligible of the trial and will show consent to the test.\n\nExclusion Criteria:\n\n1. any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml.\n2. disfunction of the heart, lung, kidney, or brain.\n3. any other disease might affect the trial .\n4. the patients would not sign the consent to the trial.'}, 'identificationModule': {'nctId': 'NCT00825669', 'briefTitle': 'Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection', 'orgStudyIdInfo': {'id': 'EHBH-RCT-2008-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'survival rate (TACE)', 'description': 'to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT', 'interventionNames': ['Drug: TACE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'survival rate (TACE plus laser ablation)', 'description': 'to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT', 'interventionNames': ['Drug: TACE', 'Procedure: Laser ablation']}], 'interventions': [{'name': 'TACE', 'type': 'DRUG', 'otherNames': ['TAE'], 'description': 'TACE: The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery. The chemotherapeutic drugs include 5-Fu 1500 mg, epirubicin 30 mg, cisplatin 30 mg.', 'armGroupLabels': ['survival rate (TACE plus laser ablation)', 'survival rate (TACE)']}, {'name': 'Laser ablation', 'type': 'PROCEDURE', 'otherNames': ['Microinvasive'], 'description': 'Laser ablation is given to the PVTT.', 'armGroupLabels': ['survival rate (TACE plus laser ablation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'shen feng, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University'}]}, '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'}}}}