Bronchoalveolar Lavage (BAL)NCT07130110
BAL Contribution to Lung Cryo-TBB in ILD
A study testing Transbronchial cryobiopsy and Bronchoalveolar Lavage in people with Bronchoalveolar Lavage (BAL) and Transbronchial Cryobiopsy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Bronchoalveolar Lavage (BAL), Transbronchial Cryobiopsy, Interstitial Lung Disease (ILD)
- What is being tested?
- Transbronchial cryobiopsy and Bronchoalveolar Lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being under 18 years of age,
- Patients diagnosed with malignancy,
- Patients who underwent non-standardized bronchoalveolar lavage,
- Patients whose data are unavailable
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kazlıçeşme Mh, Belgrad Kapı yolu Cad No:1, 34020 Zeytinburnu/İstanbul
Istanbul
About this study
Official title: Diagnostic Contribution of Bronchoalveolar Lavage to Lung Cryotransbronchial Biopsy in Interstitial Lung Diseases
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:
Read more
- 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.
Read the 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.
- Being tested
- Transbronchial cryobiopsy, Bronchoalveolar Lavage
- Keywords
- Interstitial Lung Disease, Bronchoalveolar lavage, Cryotransbronchial biopsy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial cryobiopsyDiagnostic 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 LavageDiagnostic 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%.
| Study group | Role | What they receive |
|---|---|---|
| Research group | Experimental | A group investigating the contribution of bronchoalveolar lavage to the diagnosis in patients undergoing cryo-transbronchial biopsy for interstitial lung diseases Receives: Diagnostic Test: Transbronchial cryobiopsy; Diagnostic Test: Bronchoalveolar Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield of c-TBB
The proportion of patients in whom a histopathological diagnosis was established using transbronchial cryobiopsy (c-TBB).
Measured: Within 1 week after the procedure
Secondary outcomes (3)
Contribution of BAL to Multidisciplinary Diagnosis (MDD)
The proportion of cases where bronchoalveolar lavage (BAL) provided additional diagnostic value in reaching a final diagnosis during multidisciplinary discussion.
Measured: Within 1 month of the procedure
Diagnostic Yield of Multidisciplinary Discussion in c-TBB-Negative Cases
The number and percentage of patients without histopathological diagnosis via c-TBB who were subsequently diagnosed through MDD.
Measured: Within 1 month of the procedure
Procedure-Related Complications of c-TB
The rate and type of complications observed following the c-TBB procedure.
Measured: Within 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start20 Dec 2023
- Primary completion21 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoalveolar Lavage (BAL)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Yedikule Training and Research Hospital
- Responsible party
- Principal investigator, ERDOGAN CETINKAYA, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130110
- Sponsor's protocol ID
- Cryobiopsy+BAL
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Contribution of Bronchoalveolar Lavage to Lung Cryotransbronchial Biopsy in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT07130110
- Acronym / sponsor ID
- Cryobiopsy+BAL
- Keywords
- Interstitial Lung Disease, Bronchoalveolar lavage, Cryotransbronchial biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Yedikule Training and Research Hospital
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Diagnostic Test: Transbronchial cryobiopsy, Diagnostic Test: Bronchoalveolar LavageA group investigating the contribution of bronchoalveolar lavage to the diagnosis in patients undergoing cryo-transbronchial biopsy for interstitial lung diseases |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Being under 18 years of age,
- Patients diagnosed with malignancy,
- Patients who underwent non-standardized bronchoalveolar lavage,
- Patients whose data are unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbronchial cryobiopsyThe 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 | Research group |
| Bronchoalveolar LavageThe 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%. | Diagnostic test | Research group |
Primary outcome
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).
3 secondary outcomes
Contribution of BAL to Multidisciplinary Diagnosis (MDD)
Time frame: Within 1 month of the procedure
Diagnostic Yield of Multidisciplinary Discussion in c-TBB-Negative Cases
Time frame: Within 1 month of the procedure
Procedure-Related Complications of c-TB
Time frame: Within 48 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial cryobiopsy and Bronchoalveolar Lavage in people with Bronchoalveolar Lavage (BAL) and Transbronchial Cryobiopsy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield of c-TBB (time frame: Within 1 week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.