Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02245295
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Sedation Technique in EBUS-TBNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016292', 'term': 'Conscious Sedation'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2014-09-15', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': '1-6 months', 'description': 'Sensitivity, negative predictive value'}], 'secondaryOutcomes': [{'measure': 'Lymph node morphology', 'timeFrame': '1-6 months', 'description': 'Impact of lymph node size on diagnostic accuracy'}, {'measure': 'EBUS technique', 'timeFrame': '1-6 months', 'description': 'Impact of EBUS technique (number of needle passes) on diagnostic accuracy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bronchial endoscopy', 'ultrasound', 'EBUS', 'anesthesia', 'lung cancer', 'diagnosis including staging'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).\n\nThe first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.', 'detailedDescription': 'Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with enlarged or suspicious mediastinal and/or hilar lymph nodes, in whom EBUS-TBNA is indicated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EBUS-TBNA\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02245295', 'briefTitle': 'The Role of Sedation Technique in EBUS-TBNA', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)', 'orgStudyIdInfo': {'id': 'EBUSEDA1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EBUS-TBNA', 'description': 'EBUS-TBNA for enlarged mediastinal/hilar lymph nodes', 'interventionNames': ['Procedure: Moderate Sedation for EBUS/TBNA', 'Procedure: General anesthesia for EBUS/TBNA']}], 'interventions': [{'name': 'Moderate Sedation for EBUS/TBNA', 'type': 'PROCEDURE', 'description': 'EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).', 'armGroupLabels': ['EBUS-TBNA']}, {'name': 'General anesthesia for EBUS/TBNA', 'type': 'PROCEDURE', 'description': 'EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)', 'armGroupLabels': ['EBUS-TBNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Daniel Franzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Pulmonology'}, {'name': 'Malcolm Kohler, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Pulmonology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}