Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:27 AM
Study NCT ID:
NCT07432503
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Yield and Safety of Lung Biopsy Techniques in Interstitial Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional three arm parallel-group randomized non controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Yield of Different Lung Biopsy Techniques', 'timeFrame': 'At time of biopsy procedure(day 0)', 'description': 'Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases'}], 'secondaryOutcomes': [{'measure': 'Complication Rate of Lung Biopsy Techniques', 'timeFrame': 'Within 30 days after the biopsy procedure', 'description': 'Assessment of procedure-related complications including pneumothorax, hypoxemia ,bleeding, and respiratory deterioration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial Lung Diseases', 'Cryobiopsy', 'Thoracoscopic'], 'conditions': ['Interstitial Lung Diseases (ILD)', 'Hypersenstivity Pneumonitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Samarelli AV, Tonelli R, Marchioni A, et al. (2021) Fibrotic Idiopathic Interstitial Lung Disease: The Molecular and Cellular Key Players. Int J Mol Sci 22(16). https://doi.org/10.3390/ijms22168952 2. Raghu G, Collard HR, Egan JJ, et al. (2011) An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med 183(6):788-824.https://doi.org/10.1164/rccm.2009-040GL 3. Dhooria S, Sehgal IS, Aggarwal AN, et al. (2016) Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta Analysis. Respir Care 61(5):700-712. https://doi.org/10.4187/respcare.04488'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the diagnostic yield and safety of different lung biopsy techniques in patients with interstitial lung diseases (ILD). The study compares transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and thoracoscopic lung biopsy in terms of their ability to provide accurate diagnosis and associated complications. Interstitial lung diseases represent a heterogeneous group of diffuse parenchymal lung disorders that often require histopathological confirmation. This study will help determine the most effective and safest biopsy technique to improve diagnostic accuracy and patient outcomes.', 'detailedDescription': 'Interstitial lung diseases (ILD) are a diverse group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis. Accurate diagnosis is essential for appropriate management and prognosis. Lung biopsy is often required when clinical and radiological findings are inconclusive. Several biopsy techniques are available, including transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and surgical thoracoscopic lung biopsy.\n\nTransbronchial forceps biopsy is widely available but may have limited diagnostic yield due to small specimen size. Cryobiopsy provides larger tissue samples with better preservation of lung architecture, potentially improving diagnostic accuracy. Thoracoscopic lung biopsy is considered the gold standard but is more invasive and associated with higher risk.\n\nThis study aims to compare the diagnostic yield and safety profile of these biopsy techniques in patients with suspected interstitial lung diseases. The results of this study may help guide clinicians in selecting the most appropriate biopsy technique while minimizing complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 years\n* patients with no absolute contraindications for procedure\n* cases who had clinical, laboratory and radiological criteria of ILD\n\nExclusion Criteria:\n\n* patients with images typical of definite UIP and definite extrinsic allergic alveolitis\n* clinical and radiological evidence of occupational lung diseases\n* coagulation disorder, advanced uncompensated heart disease, uncompensated Type II Respiratory failure, severe grades of pulmonary hypertension\n* pulmonary metastasis or lymphangitis carcinomatosis\n* specific parenchymal pattern "honeycombing, probable UIP, diffuse end stage fibrosis, cystic lung diseases and advanced LAM and PLCH'}, 'identificationModule': {'nctId': 'NCT07432503', 'acronym': 'DYSAFE-ILD', 'briefTitle': 'Diagnostic Yield and Safety of Lung Biopsy Techniques in Interstitial Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Diagnostic Yield and Safety of Transbronchial Lung Biopsy With Forceps,Cryo-biopsy or Thoracoscopic Lung Biopsy in Interstitial Lung Diseases', 'orgStudyIdInfo': {'id': 'MD.22.01.586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'forceps biopsy', 'description': 'patients undergo bronchoscopic transbronchial forceps biopsy', 'interventionNames': ['Procedure: Transbronchial forceps biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryobiopsy', 'description': 'Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis', 'interventionNames': ['Procedure: transbronchial cryobiopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracoscopic biopsy', 'description': 'Surgical thoracoscopic procedure to obtain lung tissue samples', 'interventionNames': ['Procedure: thoracoscopic lung biopsy']}], 'interventions': [{'name': 'Transbronchial forceps biopsy', 'type': 'PROCEDURE', 'description': 'Patients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis', 'armGroupLabels': ['forceps biopsy']}, {'name': 'transbronchial cryobiopsy', 'type': 'PROCEDURE', 'description': 'Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis', 'armGroupLabels': ['Cryobiopsy']}, {'name': 'thoracoscopic lung biopsy', 'type': 'PROCEDURE', 'description': 'Surgical thoracoscopic procedure to obtain lung tissue samples', 'armGroupLabels': ['Thoracoscopic biopsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals ,Chest Medicine Department', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed AbdElmoniem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of chest medicine faculty of medicine Mansoura university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared to protect patient confidentiality and privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}