BAL Contribution to Lung Cryo-TBB in ILD

NCT07130110 | Completed

• 1 other identifier: Cryobiopsy+BAL
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Interstitial Lung Disease; Bronchoalveolar lavage; Cryotransbronchial biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield of c-TBB

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

  Within 1 week after the procedure

Secondary Outcomes (3)

• Contribution of BAL to Multidisciplinary Diagnosis (MDD)

  Within 1 month of the procedure

• Diagnostic Yield of Multidisciplinary Discussion in c-TBB-Negative Cases

  Within 1 month of the procedure

• Procedure-Related Complications of c-TB

  Within 48 hours after the procedure

Study Arms (1)

Research group

EXPERIMENTAL

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

Diagnostic Test: Transbronchial cryobiopsy; Diagnostic Test: Bronchoalveolar Lavage

Interventions

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.

Research group

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%.

Research group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Yedikule Training and Research Hospital: collaborator

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: December 20, 2023
• Primary Completion: June 21, 2024
• Study Completion: September 30, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

TU (1)