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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.
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.
Transbronchial 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.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| forceps biopsy | Experimental | patients undergo bronchoscopic transbronchial forceps biopsy |
|
| Cryobiopsy | Active Comparator | Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis |
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| Thoracoscopic biopsy | Active Comparator | Surgical thoracoscopic procedure to obtain lung tissue samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transbronchial forceps biopsy | Procedure | Patients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield of Different Lung Biopsy Techniques | Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases | At time of biopsy procedure(day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate of Lung Biopsy Techniques | Assessment of procedure-related complications including pneumothorax, hypoxemia ,bleeding, and respiratory deterioration. | Within 30 days after the biopsy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed AbdElmoniem | Lecturer of chest medicine faculty of medicine Mansoura university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals ,Chest Medicine Department | Al Mansurah | Dakahlia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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Individual participant data will not be shared to protect patient confidentiality and privacy
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Interventional three arm parallel-group randomized non controlled
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| transbronchial cryobiopsy | Procedure | Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis |
|
| thoracoscopic lung biopsy | Procedure | Surgical thoracoscopic procedure to obtain lung tissue samples |
|