Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-22 @ 2:47 PM
Study NCT ID:
NCT02462356
Status:
UNKNOWN
Last Update Posted:
2016-04-15
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-26', 'releaseDate': '2017-06-08'}, {'releaseDate': '2018-01-04', 'unreleaseDateUnknown': True}, {'resetDate': '2018-10-25', 'releaseDate': '2018-01-17'}, {'resetDate': '2019-05-24', 'releaseDate': '2019-02-12'}], 'estimatedResultsFirstSubmitDate': '2017-06-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'short-term quality of life(EQ5D) between the two groups', 'timeFrame': 'Up to 6 month', 'description': 'To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.'}], 'secondaryOutcomes': [{'measure': 'intra-operative and postoperative complications', 'timeFrame': 'form the day of surgery up to discharege (expected within 1 month)', 'description': 'Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured.'}, {'measure': 'lung function', 'timeFrame': 'pre-operative, 3 weeks, 3 months after surgery', 'description': 'lung function will be measured at pre-operative, 3 weeks, 3 months after surgery'}, {'measure': 'Pain Scores after surgery', 'timeFrame': '1, 3 days and 1, 3 months after surgery', 'description': 'Pain Scores will be measured by Brief pain inventory'}, {'measure': "The surgeon's ergonomic influence during operation(blinks/min)", 'timeFrame': 'The video is capture every 5 minutes and lasted for 1 minute', 'description': 'Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CVATS', 'UVATS', 'perioperative effect', 'ergonomic influence'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33080728', 'type': 'DERIVED', 'citation': 'Yao J, Chang Z, Zhu L, Fan J. Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22719. doi: 10.1097/MD.0000000000022719.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.', 'detailedDescription': "Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.\n\nHowever, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;\n* Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;\n* Patients with an American Society of Anesthesiology score of 0-1.\n\nExclusion Criteria:\n\n* Patients with N2 or N3 positive or distant metastasis.\n* Patients who had undergone Neoadjuvant chemotherapy.\n* Patients with tumor invasion to the peripheral structures.\n* Patients with previous history of thoracic operations.\n* Patients with serious thoracic adhesion.\n* Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.\n* Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;\n* Patients with cardiac, hepatic, or renal dysfunction;'}, 'identificationModule': {'nctId': 'NCT02462356', 'acronym': 'MVUVLC', 'briefTitle': 'Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC', 'orgStudyIdInfo': {'id': 'LY15H160034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional VATS', 'description': 'Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer', 'interventionNames': ['Procedure: Conventional VATS']}, {'type': 'EXPERIMENTAL', 'label': 'Uniportal VATS', 'description': 'Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer', 'interventionNames': ['Procedure: Uniportal VATS']}], 'interventions': [{'name': 'Uniportal VATS', 'type': 'PROCEDURE', 'description': 'Uniportal VATS lobectomy and lymph node dissection will be performed in this group', 'armGroupLabels': ['Uniportal VATS']}, {'name': 'Conventional VATS', 'type': 'PROCEDURE', 'description': 'Conventional VATS lobectomy and lymph node dissection will be performed in this group', 'armGroupLabels': ['Conventional VATS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The second affiliated hospital Zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thoracic Surgery Department', 'investigatorFullName': 'Junqiang Fan', 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-08', 'type': 'RELEASE'}, {'date': '2017-10-26', 'type': 'RESET'}, {'date': '2018-01-04', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-01-17', 'type': 'RELEASE'}, {'date': '2018-10-25', 'type': 'RESET'}, {'date': '2019-02-12', 'type': 'RELEASE'}, {'date': '2019-05-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Junqiang Fan, Thoracic Surgery Department, Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}