Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03699657
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication', 'timeFrame': '1 month after RFA', 'description': 'Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.'}, {'measure': 'Volume of ablative zone', 'timeFrame': '7 days after RFA', 'description': 'Volume of ablative zone on post-RFA CT or MRI in a mm3.'}, {'measure': 'Ablation time', 'timeFrame': '1 day', 'description': 'RFA procedure time in each patient.'}, {'measure': 'Maximal diameter of ablative zone', 'timeFrame': '7 days after RFA', 'description': 'Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.'}], 'primaryOutcomes': [{'measure': 'Minimum diameter of ablative zone', 'timeFrame': '7 days after RFA', 'description': 'Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.'}], 'secondaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': '1 month', 'description': 'Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)'}, {'measure': 'IDR rate', 'timeFrame': '24 months after RFA', 'description': 'Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA'}, {'measure': 'EM rate', 'timeFrame': '24 months after RFA', 'description': 'Cumulative extrahepatic metastasis (EM) rate over two years after RFA'}, {'measure': '1-year local tumor progression (LTP)', 'timeFrame': '12 months after RFA', 'description': 'Comparison of rates of LTP in two groups in a year after RFA'}, {'measure': '2-year LTP', 'timeFrame': '24 months after RFA', 'description': 'Comparison of rates of LTP in two groups in two years after RFA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RFA'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).', 'detailedDescription': 'Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.\n\nTherefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with HCC (\\>= 1.5cm and \\< 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA\n* no history of previous locoregional treatment\n\nExclusion Criteria:\n\n* more than three HCC nodules\n* tumors abutting to the central portal vein or hepatic vein with a diameter \\> 5 mm\n* Child-Pugh class C\n* tumors with major vascular invasion\n* extrahepatic metastasis\n* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)'}, 'identificationModule': {'nctId': 'NCT03699657', 'briefTitle': 'Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode', 'orgStudyIdInfo': {'id': 'SNUH-2014-0279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RFA with DSM mode', 'description': 'RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.', 'interventionNames': ['Device: DSM', 'Device: Separable clustered electrodes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RFA with SSM mode', 'description': 'RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.', 'interventionNames': ['Device: SSM', 'Device: Separable clustered electrodes']}], 'interventions': [{'name': 'DSM', 'type': 'DEVICE', 'description': 'Monopolar RFA using dual switching mode (DSM)', 'armGroupLabels': ['RFA with DSM mode']}, {'name': 'SSM', 'type': 'DEVICE', 'description': 'Monopolar RFA using single switching mode (SSM)', 'armGroupLabels': ['RFA with SSM mode']}, {'name': 'Separable clustered electrodes', 'type': 'DEVICE', 'otherNames': ['Octopus®'], 'description': 'A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.', 'armGroupLabels': ['RFA with DSM mode', 'RFA with SSM mode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Min Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}