NCT07130110

BAL Contribution to Lung Cryo-TBB in ILD

Diagnostic Contribution of Bronchoalveolar Lavage to Lung Cryotransbronchial Biopsy in Interstitial Lung Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate whether performing bronchoalveolar lavage (BAL) simultaneously with transbronchial lung cryobiopsy (c-TBB) can improve diagnostic yield in adult patients with suspected interstitial lung disease (ILD). The main questions it aims to answer are: * Does the addition of BAL to c-TBB increase the overall diagnostic accuracy in ILD patients? * Can the combination of BAL and c-TBB reduce the need for surgical lung biopsy in the diagnostic process of ILD? If there is a comparison group: Researchers will compare patients diagnosed by c-TBB alone to those evaluated with both c-TBB and BAL to see if BAL provides additional diagnostic value, especially in cases where histopathological findings from c-TBB are inconclusive. Participants will: Undergo transbronchial lung cryobiopsy (c-TBB) under general anesthesia to collect lung tissue samples. Have bronchoalveolar lavage (BAL) performed in the same session using ATS guideline-based protocols. Be evaluated in a multidisciplinary discussion (MDD) integrating clinical, radiologic, and pathologic findings to establish a final diagnosis.

Detailed description

Interstitial Lung Diseases (ILDs) are a rare group of diseases characterized by inflammation and fibrosis of the lung interstitium, with many subtypes. The incidence is reported as approximately 75 per 100,000 in the US and Europe, and 25.8 in Turkey. ILDs are classified into known causes, idiopathic interstitial pneumonias (IIPs), granulomatous diseases, and other subgroups. While surgical lung biopsy remains the gold standard for diagnosis, it carries risk of complications. Therefore, cryobiopsy (c-TBB), a minimally invasive method, is preferred, with diagnostic yield ranging between 50-90%. Bronchoalveolar lavage (BAL) provides cellular analysis from the alveoli, aiding differential diagnosis in ILD but is limited as a sole diagnostic tool. Combined use of c-TBB and BAL may improve diagnostic accuracy and reduce the need for surgical biopsy. In this study, the diagnostic contribution of simultaneous BAL in patients undergoing c-TBB with a preliminary ILD diagnosis was investigated.

Conditions

• Bronchoalveolar Lavage (BAL)
• Transbronchial Cryobiopsy
• Interstitial Lung Disease (ILD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transbronchial cryobiopsy	The c-TBB procedure was performed under general anesthesia with rigid bronchoscopy guidance. The biopsy site was selected based on the area of highest involvement seen on thoracic CT. After evaluating the trachea and main bronchi with a rigid bronchoscope, a flexible bronchoscope was advanced into the target segment. Using a 1.9 mm, 90 cm cryoprobe, tissue was frozen and rapidly retracted with the bronchoscope to obtain the biopsy. The specimen was placed in formalin without damage. Hemorrhage control was achieved with a Fogarty balloon. A chest X-ray was taken two hours later to check for pneumothorax risk.
DIAGNOSTIC_TEST	Bronchoalveolar Lavage	The BAL protocol, including pre-procedural preparations and the procedure itself, was performed in accordance with the American Thoracic Society (ATS) guidelines. In cases of diffuse involvement, BAL was performed from the middle lobe or lingula, while in localized involvement, it was done from the affected area. The target segment was occluded with the bronchoscope, and room-temperature 0.9% NaCl solution was instilled in 20 cc portions and gently aspirated to prevent airway collapse. A minimum of 100 mL (maximum 300 mL) saline was used, with at least 30% recovery required. Cellular analysis of BAL fluid was conducted per ATS guidelines. Normal cell distribution: alveolar macrophages \>85%, lymphocytes 10-15%, neutrophils ≤3%, eosinophils ≤1%, squamous/ciliated columnar epithelial cells ≤1%.

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-06-21
• Completion: 2024-09-30
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: Turkey (Türkiye)