Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT00997594
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yama@clin.medic.mie-u.ac.jp', 'phone': '+81-59-231-5029', 'title': 'Dr. Koichiro Yamakado', 'phoneExt': '5630', 'organization': 'Mie University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small patient series is one of limitations of this study'}}, 'adverseEventsModule': {'timeFrame': '1 week to 1 year (mean, 215 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Adrenal Radiofrequency Ablation', 'description': 'Patients who received adrenal radiofrequency (RF) ablation.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Abdominal Radiofrequency Ablation Other Than Adrenal Gland', 'description': 'Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increase in Catecholamine', 'timeFrame': 'One day', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Increase in Cortisol', 'timeFrame': '1 day', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Cathecholamine Levels', 'paramType': 'MEAN', 'timeFrame': 'around one year', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-10'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adrenal Radiofrequency Ablation', 'description': 'Patients who received adrenal radiofrequency (RF) ablation.'}, {'id': 'OG001', 'title': 'Abdominal Radiofrequency Ablation Other Than Adrenal Gland', 'description': 'Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Just a comparison of the percentage of hypertension between the 2 patient groups.'}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adrenal Radiofrequency Ablation', 'description': 'Patients who received adrenal radiofrequency (RF) ablation.'}, {'id': 'FG001', 'title': 'Abdominal Radiofrequency Ablation Other Than Adrenal Gland', 'description': 'Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Completion of Ablation Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adrenal Radiofrequency Ablation', 'description': 'Patients who received adrenal radiofrequency (RF) ablation.'}, {'id': 'BG001', 'title': 'Abdominal Radiofrequency Ablation Other Than Adrenal Gland', 'description': 'Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '13', 'groupId': 'BG000'}, {'value': '71', 'spread': '12', 'groupId': 'BG001'}, {'value': '65', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2009-10-16', 'resultsFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-27', 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Catecholamine', 'timeFrame': 'One day'}, {'measure': 'Serum Cathecholamine Levels', 'timeFrame': 'around one year'}, {'measure': 'Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation', 'timeFrame': '1 week', 'description': 'Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.'}], 'secondaryOutcomes': [{'measure': 'Increase in Cortisol', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adrenal gland'], 'conditions': ['Adrenal Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.', 'detailedDescription': 'Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation\n* Blood pressure is 140mmHg or less before RF ablation\n* Age of 20-years or more\n* Performance status of 0 or 1\n* Agreement from the patient\n\nExclusion Criteria:\n\n* Platelet count of 50,000/mm\\^3 or International normalized ratio (INR)\\>1.5'}, 'identificationModule': {'nctId': 'NCT00997594', 'briefTitle': 'Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Mie University'}, 'officialTitle': 'Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation', 'orgStudyIdInfo': {'id': '274'}, 'secondaryIdInfos': [{'id': 'No secondary IDs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adrenal radiofrquency (RF) ablation', 'description': 'Patients who wll receive adrenal RF ablation.', 'interventionNames': ['Procedure: Radiofrequency ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abdominal RF ablation other than adrenal gland', 'description': 'Patients who will receive abdominal radiofrequency ablation other than adrenal gland.', 'interventionNames': ['Procedure: Radiofrequency ablation']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.', 'armGroupLabels': ['Abdominal RF ablation other than adrenal gland', 'Adrenal radiofrquency (RF) ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie University Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie University', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}], 'overallOfficials': [{'name': 'Koichiro Yamakado, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mie University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mie University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Koichiro Yamakado', 'investigatorAffiliation': 'Mie University'}}}}