Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT01985659
Status:
UNKNOWN
Last Update Posted:
2013-11-15
First Post:
2013-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nodal Upstaging in VATS Anatomical Resections for NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-10', 'studyFirstSubmitDate': '2013-11-10', 'studyFirstSubmitQcDate': '2013-11-10', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of N upstaging', 'timeFrame': 'at time of surgical resection', 'description': 'clinical N0 to pathological N1 clinical N0 to pathological N2 clinical N1 to pathological N2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymph Node Excision', 'Thoracic Surgical Procedures', 'Thoracic Surgery, Video-Assisted', 'Thoracotomy'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'This study investigates peropeative nodal upstaging during anatomical resections for non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case of comparable study groups, unchanged pretreatment staging and equal quality of pathologic examination, lymph node upstaging is a marker of surgical quality and can be used to study the quality of a new surgical technique.', 'detailedDescription': 'Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure is believed to achieve equal oncologic results and survival, perhaps better.\n\nPublications have shown that mediastianal lymph node dissection during VATS is similar.\n\nHowever, two recent reports have shown potential lower N1 (hilar and intrapulmonary) upstaging in VATS surgery After optimal staging the percentage of unforeseen N+ the percentage of unforeseen positive nodes can reach 15%\n\nNodal upstaging at final pathology is dependent on the quality of:\n\n* pretreatment staging, the better, the less upstaging\n* surgery, ie mediastinal, hilar and intrapulmonary lymphadenectomy\n* pathologic examination If we accept that pretreatment staging and pathologic examination are equal in two comparable surgical cohorts, the finding of unforeseen N+ or nodal upstaging is a quality marker of surgery. When surgical techniques are changing, it is important to look at this marker.\n\nIn absence of a randomized trial, we believe a cohort analysis is useful. By including all patients, open or vats, and comparing cohorts instead of the surgical technique used, the selection bias is absent. We compare three cohorts. In the first (20007-2009) almost all patients where operated through a thoracotomy. In a second cohort, (2010-2011) the experience with vats was early. In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'By including all patients, open or VATS, and comparing cohorts instead of the surgical technique used, the selection bias is absent. We compare three cohorts. In the first (20007-2009) almost all patients where operated through a thoracotomy. In a second cohort, (2010-2011) the experience with vats was early. In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cN0, cN1 patients that underwent segmentectomy, lobectomy, sleeve lobectomy for NSCLC.\n\nExclusion Criteria:\n\n* cN2\n* cM+\n* Pneumonectomy\n* Previous lung cancer surgery - lymphadenectomy\n* Neo-adjunvant therapy\n* Lung Tx\n* Bilateral lesions'}, 'identificationModule': {'nctId': 'NCT01985659', 'briefTitle': 'Nodal Upstaging in VATS Anatomical Resections for NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': 'Cohort Analysis of Nodal Upstaging in the Era of Increase of VATS Anatomical Resections for NSCLC', 'orgStudyIdInfo': {'id': 'pN+VATS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'open thoracotomy', 'description': 'In the first cohort(20007-2009) almost all patients where operated through a thoracotomy.'}, {'label': 'Early VATS', 'description': 'In a second cohort, (2010-2011) the experience with vats was early.'}, {'label': 'Standardized VATS', 'description': 'In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Herbert Decaluwé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Alessia Stanzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Christophe Dooms, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Paul De Leyn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MScN', 'investigatorFullName': 'Johnny Moons', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}