Diagnostic Yield and Safety of Lung Biopsy Techniques in Interstitial Lung Diseases (DYSAFE-ILD)

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

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Diseases (ILD); Hypersenstivity Pneumonitis
• Intervention / Treatment: Procedure: Transbronchial forceps biopsy; Procedure: transbronchial cryobiopsy; Procedure: thoracoscopic lung biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt
      • Mansoura University Hospitals ,Chest Medicine Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: forceps biopsy; patients undergo bronchoscopic transbronchial forceps biopsy	Procedure: Transbronchial forceps biopsy; Patients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis
Active Comparator: Cryobiopsy; Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis	Procedure: transbronchial cryobiopsy; Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis
Active Comparator: Thoracoscopic biopsy; Surgical thoracoscopic procedure to obtain lung tissue samples	Procedure: thoracoscopic lung biopsy; Surgical thoracoscopic procedure to obtain lung tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Thoracoscopic; Cryobiopsy; Interstitial Lung Diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: MD.22.01.586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient confidentiality and privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No