BAL Contribution to Lung Cryo-TBB in ILD

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.

Conditions

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

Interventions

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%.

Sponsors & Collaborators

• Yedikule Training and Research Hospital

  collaborator OTHER

• Saglik Bilimleri Universitesi

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2024-06-21

Completion

2024-09-30

Countries

• Turkey (Türkiye)

Study Locations