Ignite Creation Date:
2025-12-24 @ 7:31 PM
Ignite Modification Date:
2026-04-13 @ 3:04 PM
Study NCT ID:
NCT02813603
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-02-07', 'releaseDate': '2018-09-16'}], 'estimatedResultsFirstSubmitDate': '2018-09-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], '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'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sample weight', 'timeFrame': 'February 2017'}], 'secondaryOutcomes': [{'measure': 'The number of complications like bleeding, infections, pneumothorax and pain', 'timeFrame': 'February 2017'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EBUS-TBNA', 'staging', 'lymph node metastases'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30914312', 'type': 'DERIVED', 'citation': 'Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.', 'detailedDescription': 'Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 Patients with lung cancer and enlarged lymph nodes will be included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged over 18\n* Patients signed written informed consent\n* Mediastinal or hilar enlarged lymph nodes (\\>10mm) in short axis radiological or clinical findings likely for lung cancer\n\nExclusion Criteria:\n\n* Severe impairment of any organs, with do not enable anaesthesia\n* Quick \\<80%, INR \\>1,5, thrombocytes \\<50/nl or PTT\\>120sec\n* Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.\n* Insufficient language ability (spoken and written German)'}, 'identificationModule': {'nctId': 'NCT02813603', 'briefTitle': 'Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes', 'orgStudyIdInfo': {'id': 'EBUS19VS22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Product (19-gauge)', 'description': 'After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle', 'interventionNames': ['Procedure: EBUS']}, {'label': 'Control Intervention (22-gauge)', 'description': 'After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle', 'interventionNames': ['Procedure: EBUS']}], 'interventions': [{'name': 'EBUS', 'type': 'PROCEDURE', 'description': '19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.', 'armGroupLabels': ['Control Intervention (22-gauge)', 'Study Product (19-gauge)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Ruhrlandklinik, University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Kaid Darwiche, PD Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'supervising doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv. Doz. Dr. med. Kaid Darwiche', 'investigatorFullName': 'Kaid Darwiche', 'investigatorAffiliation': 'University Hospital, Essen'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-09-16', 'type': 'RELEASE'}, {'date': '2019-02-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kaid Darwiche, Priv. Doz. Dr. med. Kaid Darwiche, University Hospital, Essen'}}}}