Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 6:22 PM
Study NCT ID:
NCT02180568
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipiodol Localization for Ground-glass-opacity Minimal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004998', 'term': 'Ethiodized Oil'}], 'ancestors': [{'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure success rate', 'timeFrame': 'one day', 'description': 'Procedure success was defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire.'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'one day', 'description': 'Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death'}, {'measure': 'Procedure time', 'timeFrame': '1 hour', 'description': 'Total procedure time for lung localization'}, {'measure': 'Surgery time', 'timeFrame': '12 hours', 'description': 'Surgery time for obtaining wedge resection specimen'}, {'measure': 'Safety resection margin', 'timeFrame': '1 hour', 'description': 'The safety specimen resection margin was categorized either as positive (grossly positive (R2), microscopically positive if tumor was at the inked surface (R1)), or negative (microscopically negative if there was no tumor at the inked surface (R0))'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ground-glass-opacity (GGO)', 'Lung localization', 'Lipiodol', 'Hook wire', 'Video assisted thoracic surgery (VATS)'], 'conditions': ['Pulmonary Lesion With Ground-glass-opacity']}, 'referencesModule': {'references': [{'pmid': '26093953', 'type': 'DERIVED', 'citation': 'Park CH, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon WC, Kim TH, Choi BW; LOGIS Investigators. Lipiodol lOcalization for Ground-glass opacity mInimal Surgery: Rationale and design of the LOGIS trial. Contemp Clin Trials. 2015 Jul;43:194-9. doi: 10.1016/j.cct.2015.06.009. Epub 2015 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'The study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. A total of 250 participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims of this study are achieved, the use of lipiodol localization technique will be widespread their application for localization of non-palpable pulmonary lesions that are indicated for VATS resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting adult patients ≥ 20 years of age\n* Pulmonary lesion with a ground glass opacity(GGO)component of more than 50%\n* Patient with lesion size less than 3cm\n* Persistence or growth of the established lesion within a three month period\n* Patient who are not contraindicated to surgery\n* Patients who are willing to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with solid pulmonary lesion\n* Patients with multiple GGOs need multiple localization\n* Patients who are contraindicated to surgery\n* Patients who behave in an uncooperative manner\n* Unwilling or unable to give informed consent\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02180568', 'acronym': 'LOGIS', 'briefTitle': 'Lipiodol Localization for Ground-glass-opacity Minimal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Severance Hospital'}, 'officialTitle': 'Validation Study to Evaluate the Safety and Efficacy of Preoperative Computed Tomography-guided Localization Technique Using Lipiodol for Patients With Ground Glass Opacity Pulmonary Lesions: A Prospective Multicenter Study', 'orgStudyIdInfo': {'id': 'SEV2013-0740'}, 'secondaryIdInfos': [{'id': 'F015894', 'type': 'OTHER_GRANT', 'domain': 'Guerbet Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipiodol', 'description': 'Lipiodol-guided lung localization technique', 'interventionNames': ['Procedure: Lipiodol', 'Drug: Lipiodol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hookwire', 'description': 'Hookwire-guided lung localization technique', 'interventionNames': ['Procedure: Hookwire']}], 'interventions': [{'name': 'Lipiodol', 'type': 'PROCEDURE', 'description': 'Lipiodol-guided lung localization technique', 'armGroupLabels': ['Lipiodol']}, {'name': 'Hookwire', 'type': 'PROCEDURE', 'description': 'Hookwire-guided lung localization technique', 'armGroupLabels': ['Hookwire']}, {'name': 'Lipiodol', 'type': 'DRUG', 'armGroupLabels': ['Lipiodol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin Hur, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University Health System, Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Severance Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Dankook University', 'class': 'OTHER'}, {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin Hur', 'investigatorAffiliation': 'Severance Hospital'}}}}