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Diagnostic Yield and Safety of Lung Biopsy Techniques in Interstitial Lung Diseases

Diagnostic Yield and Safety of Transbronchial Lung Biopsy With Forceps,Cryo-biopsy or Thoracoscopic Lung Biopsy in Interstitial Lung Diseases

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07432503
Acronym
DYSAFE-ILD
Enrollment
60
Registered
2026-02-25
Start date
2022-05-15
Completion date
2024-10-23
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersenstivity Pneumonitis, Interstitial Lung Diseases (ILD)

Keywords

Interstitial Lung Diseases, Cryobiopsy, Thoracoscopic

Brief summary

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.

Detailed description

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.

Interventions

Patients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis

Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis

PROCEDUREthoracoscopic lung biopsy

Surgical thoracoscopic procedure to obtain lung tissue samples

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Interventional three arm parallel-group randomized non controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age more than 18 years * patients with no absolute contraindications for procedure * cases who had clinical, laboratory and radiological criteria of ILD

Exclusion criteria

* patients with images typical of definite UIP and definite extrinsic allergic alveolitis * clinical and radiological evidence of occupational lung diseases * coagulation disorder, advanced uncompensated heart disease, uncompensated Type II Respiratory failure, severe grades of pulmonary hypertension * pulmonary metastasis or lymphangitis carcinomatosis * specific parenchymal pattern "honeycombing, probable UIP, diffuse end stage fibrosis, cystic lung diseases and advanced LAM and PLCH

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Yield of Different Lung Biopsy TechniquesAt time of biopsy procedure(day 0)Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases

Secondary

MeasureTime frameDescription
Complication Rate of Lung Biopsy TechniquesWithin 30 days after the biopsy procedureAssessment of procedure-related complications including pneumothorax, hypoxemia ,bleeding, and respiratory deterioration.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohamed AbdElmoniem

Lecturer of chest medicine faculty of medicine Mansoura university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026