Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT04047667
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2019-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cone Beam CT Guided Transbronchial Cryobiopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-04', 'studyFirstSubmitDate': '2019-08-04', 'studyFirstSubmitQcDate': '2019-08-04', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety profile of procedure', 'timeFrame': '30 days', 'description': 'pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.'}], 'secondaryOutcomes': [{'measure': 'diagnostic efficacy', 'timeFrame': '30 days', 'description': 'diagnostic yield'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ILD']}, 'referencesModule': {'references': [{'pmid': '38910197', 'type': 'DERIVED', 'citation': 'Bian Y, Deng M, Gao Q, Zhou G, Tong R, Zhao L, Liu M, Sun J, Dai H, Herth FJF, Hou G, Wang C. The Diagnostic Efficiency and Safety of Transbronchial Lung Cryobiopsy Using 1.1-mm Cryoprobe in Diagnosing Interstitial Lung Disease. Lung. 2024 Oct;202(5):615-623. doi: 10.1007/s00408-024-00713-2. Epub 2024 Jun 23.'}, {'pmid': '38702744', 'type': 'DERIVED', 'citation': 'Bian Y, Zhou G, Gao Q, Deng M, Tong R, Xia Y, Lin J, Hou G, Dai H. Assessment of a randomized controlled trial on the safety of pre-placing bronchial balloons in transbronchial lung cryobiopsy for diagnosing interstitial lung disease. Eur J Med Res. 2024 May 3;29(1):268. doi: 10.1186/s40001-024-01871-y.'}]}, 'descriptionModule': {'briefSummary': 'Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients with TBCB.\n\nCone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were close to the image qualities of conventional CT. The probe-to-pleura relationship could be accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved under the guidance of CBCT. In this study, we conducted a prospective study to observe the safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ILD Patients without a diagnosis after integration of clinical profile, laboratory tests and HRCT features', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%\n\nExclusion Criteria:\n\n* acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L'}, 'identificationModule': {'nctId': 'NCT04047667', 'briefTitle': 'Cone Beam CT Guided Transbronchial Cryobiopsy', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'The Safety and Diagnostic Efficacy of Cone Beam CT Guided Transbronchial Cryobiopsy for ILD Patients', 'orgStudyIdInfo': {'id': 'ChinaJapanFH004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CBCT guided TBCB', 'description': 'Patients with ILD who met the following including criteria from September 2018 to July 2019 were suggested to receive TBCB under CBCT guidance: more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%, patients without acute exacerbation within one month, patients without bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients without pulmonary hypertension, respiratory failure, liver or kidney disfunction, or cardiac insufficiency, PLT more than 50 x 109/L. All included patients signed the informed consent.', 'interventionNames': ['Procedure: cone beam CT guided transbronchial cryobiopsy']}], 'interventions': [{'name': 'cone beam CT guided transbronchial cryobiopsy', 'type': 'PROCEDURE', 'description': 'CBCT images are acquried and reviewed in axial, coronal and sagittal planes to most accurately assess the cryoprobe position within the lung parenchyma and relative to other thoracic structures. The minimum probe-to-pleura distance will be measured. If the position of cryoprobe is proper, TBCB will be perfomed.', 'armGroupLabels': ['CBCT guided TBCB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaping Dai, MD', 'role': 'CONTACT', 'email': 'daihuaping@sina.com', 'phone': '0086-13901293597'}, {'name': 'Guowu Zhou, MD', 'role': 'CONTACT', 'email': 'gwzhou41@163.com', 'phone': '0086-13585939427'}, {'name': 'Guowu Zhou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice Director of Respiratory disease Center', 'investigatorFullName': 'Dai Huaping', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}