Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01340105
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2011-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
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': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'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': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-05', 'studyFirstSubmitDate': '2011-04-19', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete ablation rate', 'timeFrame': '1 month', 'description': 'Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)'}], 'secondaryOutcomes': [{'measure': 'Treatment related mortality', 'timeFrame': '30-day', 'description': 'Mortality within 30 days after operation'}, {'measure': 'Recurrent disease', 'timeFrame': '3 year', 'description': 'It is defined as the imaging detected new lesions'}, {'measure': 'Survival', 'timeFrame': '3 year', 'description': 'Overall and disease-free survival'}, {'measure': 'Long-term liver function', 'timeFrame': '3 year', 'description': 'Monitoring of liver function test result and the occurrance of decompensated cirrhosis'}, {'measure': 'Treatment related morbidity', 'timeFrame': '30-day', 'description': 'Complications related to the treatment received'}, {'measure': 'Hospital stay', 'timeFrame': '30-day', 'description': 'Total length of hospital stay (days)'}]}, 'conditionsModule': {'keywords': ['Microwave ablation', 'Radiofrequency ablation', 'Randomised controlled trial'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).\n\nThe investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.\n\nA randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years\n* Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation\n* Resectable HCC but patient opts for local ablation\n* Maximum diameter of tumor ≤6cm\n* Maximum number of tumor nodules ≤3\n* Absence of radiology evidence of major vascular or bile duct invasion\n* Child's A or B liver function\n* Karnofsky performance status ≥70%\n\nExclusion Criteria:\n\n* Informed consent not available\n* Pregnant female patients\n* Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)\n* HCC with history of rupture\n* Concomitant hepatectomy\n* Patients with chronic renal failure"}, 'identificationModule': {'nctId': 'NCT01340105', 'briefTitle': 'Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': 'CT11005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microwave', 'description': 'Hepatocellular carcinoma treated with microwave ablation', 'interventionNames': ['Procedure: Microwave ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency', 'description': 'Hepatocellular carcinoma treated with radiofrequency ablation', 'interventionNames': ['Procedure: Radiofrequency ablation']}], 'interventions': [{'name': 'Microwave ablation', 'type': 'PROCEDURE', 'description': 'Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.', 'armGroupLabels': ['Microwave']}, {'name': 'Radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.', 'armGroupLabels': ['Radiofrequency']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kit-fai Lee, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, The Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant', 'investigatorFullName': 'Cheung Yue Sun', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}