Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-28 @ 8:14 AM
Study NCT ID:
NCT02579304
Status:
UNKNOWN
Last Update Posted:
2018-05-24
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Transbronchial Lung Cryobiopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'transbronchial lung biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'histopathological agreement', 'timeFrame': '2 years', 'description': 'Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)'}], 'secondaryOutcomes': [{'measure': 'procedural safety : bleeding', 'timeFrame': 'periprocedural 1 hour', 'description': 'incidence of bleeding (number of case)'}, {'measure': 'procedural safety : bleeding (2)', 'timeFrame': 'periprocedural 1 hour', 'description': 'severity of bleeding (grade 1-2-3)'}, {'measure': 'procedural safety : bleeding (3)', 'timeFrame': 'periprocedural 1 hour', 'description': 'duration of bleeding (seconds)'}, {'measure': 'procedural safety : penumothorax', 'timeFrame': 'periprocedural 1 hour', 'description': 'pneumothorax rate (number of cases)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics', 'detailedDescription': 'Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.\n\nAgreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'interstitial lung disease, fibrotic or non-fibrotic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Case of DILD presented at the MDD\n* Referral for VATS biopsy as advised by MDD.\n* Informed consent available\n* Age \\> 18\n* FVC \\> 50%pred\n* DLCO \\> 40%pred\n* PaO2 \\> 65 mmHg, pCO2 \\< 45 mmHg\n* No exclusion criteria\n\nExclusion Criteria:\n\n* \\- Age \\> 75\n* PAPS \\>40mmHg as measured on transthoracic cardiac ultrasound\n* Platelet count \\<100000/µl\n* INR \\> 1.4\n* BMI \\>30\n* Diffuse bullous lung disease\n* Active anti-platelet or anticoagulant treatment\n* Active heart failure or unstable coronary heart disease\n* Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist'}, 'identificationModule': {'nctId': 'NCT02579304', 'briefTitle': 'Diagnostic Value of Transbronchial Lung Cryobiopsy', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.', 'orgStudyIdInfo': {'id': 'UZLPNE1015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transbronchial lung cryobiopsy', 'type': 'PROCEDURE', 'description': 'bronchoscopic sampling'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'jonas Yserbyt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yserbyt Jonas', 'investigatorAffiliation': 'KU Leuven'}}}}