Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-16 @ 6:11 AM
Study NCT ID:
NCT03806218
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent 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': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', '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': '3 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.'}], 'primaryOutcomes': [{'measure': 'Minimum diameter of ablation zone per unit time', 'timeFrame': '3 days after RFA', 'description': 'Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.'}], 'secondaryOutcomes': [{'measure': 'Technique efficacy', 'timeFrame': '1 month after RFA', 'description': 'Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)'}, {'measure': 'IDR rate', 'timeFrame': '12 months, 24 months after RFA', 'description': 'Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA'}, {'measure': 'EM rate', 'timeFrame': '12 months, 24 months after RFA', 'description': 'Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA'}, {'measure': 'Local tumor progression (LTP)', 'timeFrame': '12 months, 24 months after RFA', 'description': 'Cumulative LTP rates in two groups in 2 years after RFA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RFA'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32986758', 'type': 'DERIVED', 'citation': 'Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment\n* HCC nodules measuring 1 cm or larger and smaller than 5 cm\n\nExclusion Criteria:\n\n* more than three HCC nodules\n* tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \\> 5mm\n* extrahepatic metastasis\n* Child-Pugh class C\n* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)'}, 'identificationModule': {'nctId': 'NCT03806218', 'briefTitle': 'Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study', 'orgStudyIdInfo': {'id': 'SNUH-2015-0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TICW-RFA', 'description': 'Bipolar RFA using twin internally cooled-wet electrodes', 'interventionNames': ['Device: Bipolar RFA', 'Device: Twin internally cooled-wet electrodes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SC-RFA', 'description': 'Switching monopolar RFA using separable clustered electrodes', 'interventionNames': ['Device: SM-RFA', 'Device: Separable clustered electrodes']}], 'interventions': [{'name': 'Bipolar RFA', 'type': 'DEVICE', 'description': 'Bipolar RFA in which RF currents flow between two electrodes', 'armGroupLabels': ['TICW-RFA']}, {'name': 'SM-RFA', 'type': 'DEVICE', 'description': 'Monopolar RFA using multiple electrodes with switching mode', 'armGroupLabels': ['SC-RFA']}, {'name': 'Twin internally cooled-wet electrodes', 'type': 'DEVICE', 'otherNames': ['CWTN-T'], 'description': 'Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity', 'armGroupLabels': ['TICW-RFA']}, {'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': ['SC-RFA']}]}, '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'}}}}