Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-02 @ 10:38 PM
Study NCT ID:
NCT02540694
Status:
UNKNOWN
Last Update Posted:
2015-09-04
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS vs EUS-B for Diagnosing Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019160', 'term': 'Endosonography'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.', 'timeFrame': '2 weeks after the endosonography procedure.'}, {'measure': 'Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.', 'timeFrame': '9 months after inclusion of last patient.', 'description': 'The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sarcoidosis', 'Endosonography']}, 'referencesModule': {'references': [{'pmid': '34792268', 'type': 'DERIVED', 'citation': 'Crombag LMM, Mooij-Kalverda K, Szlubowski A, Gnass M, Tournoy KG, Sun J, Oki M, Ninaber MK, Steinfort DP, Jennings BR, Liberman M, Bilaceroglu S, Bonta PI, Korevaar DA, Trisolini R, Annema JT. EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial. Respirology. 2022 Feb;27(2):152-160. doi: 10.1111/resp.14182. Epub 2021 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'Rationale:\n\nEndosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion.\n\nSecondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates.\n\nHypotheses:\n\n1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II.\n2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II.\n\nStudy design:\n\nInvestigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals)\n\nStudy population:\n\nConsecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion.\n\nIntervention:\n\nEBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.\n\nMain study endpoints:\n\n1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.\n2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)\n* Indication for tissue verification of noncaseating granuloma's\n* Provision of a written informed consent\n\nExclusion Criteria:\n\n* Life expectancy of less than 6 months\n* Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node)\n* Positive acid-fast bacilli sputum test\n* Contra-indication for endosonography\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02540694', 'briefTitle': 'EBUS vs EUS-B for Diagnosing Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -', 'orgStudyIdInfo': {'id': 'NL51598.018.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EBUS-TBNA using 22G needle', 'description': 'EBUS-TBNA using 22G needle (transbronchial route)', 'interventionNames': ['Device: Endosonography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EBUS-TBNA using 25G ProCore needle', 'description': 'EBUS-TBNA using 25G ProCore needle (transbronchial route)', 'interventionNames': ['Device: Endosonography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EUS-B-FNA using 22G needle', 'description': 'EUS-B-FNA using 22G needle (transoesophageal route)', 'interventionNames': ['Device: Endosonography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EUS-B-FNA using 25G ProCOre needle', 'description': 'EUS-B-FNA using 25G ProCOre needle (transoesophageal route)', 'interventionNames': ['Device: Endosonography']}], 'interventions': [{'name': 'Endosonography', 'type': 'DEVICE', 'otherNames': ['EBUS', 'EUS-B'], 'armGroupLabels': ['EBUS-TBNA using 22G needle', 'EBUS-TBNA using 25G ProCore needle', 'EUS-B-FNA using 22G needle', 'EUS-B-FNA using 25G ProCOre needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Laurence MM Crombag, MD', 'role': 'CONTACT', 'email': 'l.m.crombag@amc.nl', 'phone': '31205664356'}, {'name': 'Jouke T Annema, Prof', 'role': 'CONTACT', 'email': 'j.t.annema@amc.nl', 'phone': '31205664356'}], 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Laurence MM Crombag, MD', 'role': 'CONTACT', 'email': 'l.m.crombag@amc.nl', 'phone': '31205664356'}, {'name': 'Jouke T Annema, Prof', 'role': 'CONTACT', 'email': 'j.t.annema@amc.nl', 'phone': '31205664356'}], 'overallOfficials': [{'name': 'Jouke T Annema, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cook Medical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'L.M.M. Crombag', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}