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

NCT07432503 | Completed

• 1 other identifier: MD.22.01.586
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Diseases (ILD); Hypersenstivity Pneumonitis

Keywords

Interstitial Lung Diseases; Cryobiopsy; Thoracoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complication Rate of Lung Biopsy Techniques

  Within 30 days after the biopsy procedure

Study Arms (3)

forceps biopsy

EXPERIMENTAL

patients undergo bronchoscopic transbronchial forceps biopsy

Procedure: Transbronchial forceps biopsy

Cryobiopsy

ACTIVE COMPARATOR

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

Procedure: transbronchial cryobiopsy

Thoracoscopic biopsy

ACTIVE COMPARATOR

Surgical thoracoscopic procedure to obtain lung tissue samples

Procedure: thoracoscopic lung biopsy

Interventions

Transbronchial forceps biopsy PROCEDURE

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

forceps biopsy

transbronchial cryobiopsy PROCEDURE

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

Cryobiopsy

thoracoscopic lung biopsy PROCEDURE

Surgical thoracoscopic procedure to obtain lung tissue samples

Thoracoscopic biopsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals ,Chest Medicine Department

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed AbdElmoniem

  Lecturer of chest medicine faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional three arm parallel-group randomized non controlled

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start: May 15, 2022
• Primary Completion: March 5, 2024
• Study Completion: October 23, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)