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NCT Number: NCT07432503

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals ,Chest Medicine Department

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transbronchial forceps biopsy

Procedure

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

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

Primary outcomes

  1. Diagnostic Yield of Different Lung Biopsy Techniques

    Time frame: At 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 outcomes

  1. Complication Rate of Lung Biopsy Techniques

    Time frame: Within 30 days after the biopsy procedure

    Assessment of procedure-related complications including pneumothorax, hypoxemia ,bleeding, and respiratory deterioration.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: DYSAFE-ILD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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