BAL Contribution to Lung Cryo-TBB in ILD

NCT ID: NCT07130110

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-09-30

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Research group

A group investigating the contribution of bronchoalveolar lavage to the diagnosis in patients undergoing cryo-transbronchial biopsy for interstitial lung diseases

Group Type: EXPERIMENTAL

Transbronchial cryobiopsy

Intervention Type: 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

Intervention Type: 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%.

Interventions

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.

Intervention Type: 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%.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yedikule Training and Research Hospital

OTHER

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

ERDOGAN CETINKAYA

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Cryobiopsy+BAL

Identifier Type: -

Identifier Source: org_study_id