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Completed

NCT Number: NCT07130110

BAL Contribution to Lung Cryo-TBB in ILD

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.

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Key information

Conditions

Bronchoalveolar Lavage (BAL) Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Transbronchial Cryobiopsy

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kazlıçeşme Mh, Belgrad Kapı yolu Cad No:1, 34020 Zeytinburnu/İstanbul

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients over the age of 18,
  • Patients diagnosed with interstitial lung disease through imaging methods, and patients who underwent cryotransbronchial biopsy and bronchoalveolar lavage

Exclusion criteria

  • Being under 18 years of age,
  • Patients diagnosed with malignancy,
  • Patients who underwent non-standardized bronchoalveolar lavage,
  • Patients whose data are unavailable

Treatment and study plan

Transbronchial cryobiopsy

Diagnostic Test

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.

bronchoalveolar lavage

Diagnostic Test

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%.

Primary outcomes

  1. Diagnostic Yield of c-TBB

    Time frame: Within 1 week after the procedure

    The proportion of patients in whom a histopathological diagnosis was established using transbronchial cryobiopsy (c-TBB).

Secondary outcomes

  1. Contribution of BAL to Multidisciplinary Diagnosis (MDD)

    Time frame: Within 1 month of the procedure

    The proportion of cases where bronchoalveolar lavage (BAL) provided additional diagnostic value in reaching a final diagnosis during multidisciplinary discussion.

  2. Diagnostic Yield of Multidisciplinary Discussion in c-TBB-Negative Cases

    Time frame: Within 1 month of the procedure

    The number and percentage of patients without histopathological diagnosis via c-TBB who were subsequently diagnosed through MDD.

  3. Procedure-Related Complications of c-TB

    Time frame: Within 48 hours after the procedure

    The rate and type of complications observed following the c-TBB procedure.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Yedikule Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

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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