Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT03599505
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}], 'ancestors': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy rate of localization', 'timeFrame': 'one year', 'description': 'The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.'}], 'secondaryOutcomes': [{'measure': 'Correlation of lesion size and localization', 'timeFrame': 'one year', 'description': 'Whether lesion size affects localization will be explored in the study.'}, {'measure': 'Correlation of distance between the lesion and pleura and localization', 'timeFrame': 'one year', 'description': 'Whether distance between the lesion and pleura affects localization will be explored.'}, {'measure': 'Time of localization', 'timeFrame': 'one week', 'description': 'The time of intraoperative ultrasonographic localization will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraoperative ultrasonographic localization', 'pulmonary nodules', 'video-assisted thoracoscopic surgery'], 'conditions': ['Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '19660350', 'type': 'BACKGROUND', 'citation': 'Kondo R, Yoshida K, Hamanaka K, Hashizume M, Ushiyama T, Hyogotani A, Kurai M, Kawakami S, Fukushima M, Amano J. Intraoperative ultrasonographic localization of pulmonary ground-glass opacities. J Thorac Cardiovasc Surg. 2009 Oct;138(4):837-42. doi: 10.1016/j.jtcvs.2009.02.002. Epub 2009 Mar 26.'}, {'pmid': '15680811', 'type': 'BACKGROUND', 'citation': "Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. doi: 10.1016/j.athoracsur.2004.07.087."}, {'pmid': '20103238', 'type': 'BACKGROUND', 'citation': 'Nakashima S, Watanabe A, Obama T, Yamada G, Takahashi H, Higami T. Need for preoperative computed tomography-guided localization in video-assisted thoracoscopic surgery pulmonary resections of metastatic pulmonary nodules. Ann Thorac Surg. 2010 Jan;89(1):212-8. doi: 10.1016/j.athoracsur.2009.09.075.'}, {'pmid': '17318707', 'type': 'BACKGROUND', 'citation': 'Pittet O, Christodoulou M, Pezzetta E, Schmidt S, Schnyder P, Ris HB. Video-assisted thoracoscopic resection of a small pulmonary nodule after computed tomography-guided localization with a hook-wire system. Experience in 45 consecutive patients. World J Surg. 2007 Mar;31(3):575-8. doi: 10.1007/s00268-006-0343-7.'}, {'pmid': '17494801', 'type': 'BACKGROUND', 'citation': 'Chen W, Chen L, Yang S, Chen Z, Qian G, Zhang S, Jing J. A novel technique for localization of small pulmonary nodules. Chest. 2007 May;131(5):1526-31. doi: 10.1378/chest.06-1017.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).', 'detailedDescription': 'The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients older than 18 year-old with chest CT showing pulmonary nodule that need to undergo VATS will be enrolled in the study. Patient with severe cardiopulmonary dysfunction and other indications that can't receive VATS will be excluded.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who are older than 18 year-old.\n2. Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.\n3. Patients who have good compliance and sign informed consent.\n\nExclusion Criteria:\n\n1. Patient with severe asthma and pulmonary fibrosis.\n2. Refusal of participation.\n3. Severe cardiopulmonary dysfunction and other indications that can't receive VATS."}, 'identificationModule': {'nctId': 'NCT03599505', 'briefTitle': 'Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Intraoperative Ultrasonographic Localization of Pulmonary Nodules in Video-assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': 'Chest008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'localization group', 'type': 'PROCEDURE', 'description': 'Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531). The accuracy rate of localization will be evaluated using gray scale mode and elastography mode.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lei Wang, MD', 'role': 'CONTACT', 'email': '13917985547@163.com', 'phone': '86-021-22200000', 'phoneExt': '1416'}], 'overallOfficials': [{'name': 'Lei Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Xu Lei', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}