Interstitial Lung Diseases (ILD)DYSAFE-ILDNCT07432503
Diagnostic Yield and Safety of Lung Biopsy Techniques in Interstitial Lung Diseases
A study testing Transbronchial forceps biopsy, transbronchial cryobiopsy and thoracoscopic lung biopsy in people with Interstitial Lung Diseases (ILD) and Hypersenstivity Pneumonitis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the diagnostic yield and safety of different lung biopsy techniques in patients with interstitial lung diseases (ILD). The study compares transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and thoracoscopic lung biopsy in terms of their ability to provide accurate… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Lung Diseases (ILD), Hypersenstivity Pneumonitis
- What is being tested?
- Transbronchial forceps biopsy, transbronchial cryobiopsy and thoracoscopic lung biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2022to 23 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years
- patients with no absolute contraindications for procedure
- cases who had clinical, laboratory and radiological criteria of ILD
Who cannot join
- patients with images typical of definite UIP and definite extrinsic allergic alveolitis
- clinical and radiological evidence of occupational lung diseases
- coagulation disorder, advanced uncompensated heart disease, uncompensated Type II Respiratory failure, severe grades of pulmonary hypertension
- pulmonary metastasis or lymphangitis carcinomatosis
- specific parenchymal pattern "honeycombing, probable UIP, diffuse end stage fibrosis, cystic lung diseases and advanced LAM and PLCH
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals ,Chest Medicine Department
Al Mansurah, Dakahlia Governorate
About this study
Official title: Diagnostic Yield and Safety of Transbronchial Lung Biopsy With Forceps,Cryo-biopsy or Thoracoscopic Lung Biopsy in Interstitial Lung Diseases
This study aims to evaluate the diagnostic yield and safety of different lung biopsy techniques in patients with interstitial lung diseases (ILD). The study compares transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and thoracoscopic lung biopsy in terms of their ability to provide accurate diagnosis and associated complications. Interstitial lung diseases represent a heterogeneous group of diffuse parenchymal lung disorders that often require histopathological confirmation. This study will help determine the most effective and safest biopsy technique to improve diagnostic accuracy and patient outcomes.
Read the detailed description
Interstitial lung diseases (ILD) are a diverse group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis. Accurate diagnosis is essential for appropriate management and prognosis. Lung biopsy is often required when clinical and radiological findings are inconclusive. Several biopsy techniques are available, including transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and surgical thoracoscopic lung biopsy.
Transbronchial forceps biopsy is widely available but may have limited diagnostic yield due to small specimen size. Cryobiopsy provides larger tissue samples with better preservation of lung architecture, potentially improving diagnostic accuracy. Thoracoscopic lung biopsy is considered the gold standard but is more invasive and associated with higher risk.
This study aims to compare the diagnostic yield and safety profile of these biopsy techniques in patients with suspected interstitial lung diseases. The results of this study may help guide clinicians in selecting the most appropriate biopsy technique while minimizing complications.
- Being tested
- Transbronchial forceps biopsy, transbronchial cryobiopsy, thoracoscopic lung biopsy
- Keywords
- Interstitial Lung Diseases, Cryobiopsy, Thoracoscopic
- 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 forceps biopsyProcedure or surgery
Patients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis
transbronchial cryobiopsyProcedure or surgery
Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis
thoracoscopic lung biopsyProcedure or surgery
Surgical thoracoscopic procedure to obtain lung tissue samples
| Study group | Role | What they receive |
|---|---|---|
| forceps biopsy | Experimental | patients undergo bronchoscopic transbronchial forceps biopsy Receives: Procedure: Transbronchial forceps biopsy |
| Cryobiopsy | Active comparator | Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis Receives: Procedure: transbronchial cryobiopsy |
| Thoracoscopic biopsy | Active comparator | Surgical thoracoscopic procedure to obtain lung tissue samples Receives: Procedure: thoracoscopic lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield of Different Lung Biopsy Techniques
Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases
Measured: At time of biopsy procedure(day 0)
Secondary outcomes (1)
Complication Rate of Lung Biopsy Techniques
Assessment of procedure-related complications including pneumothorax, hypoxemia ,bleeding, and respiratory deterioration.
Measured: Within 30 days after the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 May 2022
- Primary completion5 Mar 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional three arm parallel-group randomized non controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432503
- Sponsor's protocol ID
- MD.22.01.586
- Acronym
- DYSAFE-ILD
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy
Publications
Samarelli AV, Tonelli R, Marchioni A, et al. (2021) Fibrotic Idiopathic Interstitial Lung Disease: The Molecular and Cellular Key Players. Int J Mol Sci 22(16). https://doi.org/10.3390/ijms22168952 2. Raghu G, Collard HR, Egan JJ, et al. (2011) An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med 183(6):788-824.https://doi.org/10.1164/rccm.2009-040GL 3. Dhooria S, Sehgal IS, Aggarwal AN, et al. (2016) Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta Analysis. Respir Care 61(5):700-712. https://doi.org/10.4187/respcare.04488
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield and Safety of Transbronchial Lung Biopsy With Forceps,Cryo-biopsy or Thoracoscopic Lung Biopsy in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT07432503
- Acronym / sponsor ID
- DYSAFE-ILD / MD.22.01.586
- Keywords
- Interstitial Lung Diseases, Cryobiopsy, Thoracoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 25 Feb 2026 (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.
This study aims to evaluate the diagnostic yield and safety of different lung biopsy techniques in patients with interstitial lung diseases (ILD). The study compares transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and thoracoscopic lung biopsy in terms of their ability to provide accurate diagnosis and associated complications. Interstitial lung diseases represent a heterogeneous group of diffuse parenchymal lung disorders that often require histopathological confirmation. This study will help determine the most effective and safest biopsy technique to improve diagnostic accuracy and patient outcomes.
Detailed description
Interstitial lung diseases (ILD) are a diverse group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis. Accurate diagnosis is essential for appropriate management and prognosis. Lung biopsy is often required when clinical and radiological findings are inconclusive. Several biopsy techniques are available, including transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and surgical thoracoscopic lung biopsy.
Transbronchial forceps biopsy is widely available but may have limited diagnostic yield due to small specimen size. Cryobiopsy provides larger tissue samples with better preservation of lung architecture, potentially improving diagnostic accuracy. Thoracoscopic lung biopsy is considered the gold standard but is more invasive and associated with higher risk.
This study aims to compare the diagnostic yield and safety profile of these biopsy techniques in patients with suspected interstitial lung diseases. The results of this study may help guide clinicians in selecting the most appropriate biopsy technique while minimizing complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional three arm parallel-group randomized non controlled
| Arm | Type | Receives |
|---|---|---|
| forceps biopsy | Experimental | Procedure: Transbronchial forceps biopsypatients undergo bronchoscopic transbronchial forceps biopsy |
| Cryobiopsy | Active comparator | Procedure: transbronchial cryobiopsyPatients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis |
| Thoracoscopic biopsy | Active comparator | Procedure: thoracoscopic lung biopsySurgical thoracoscopic procedure to obtain lung tissue samples |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 18 years
- patients with no absolute contraindications for procedure
- cases who had clinical, laboratory and radiological criteria of ILD
Key exclusion criteria (5 listed)
- patients with images typical of definite UIP and definite extrinsic allergic alveolitis
- clinical and radiological evidence of occupational lung diseases
- coagulation disorder, advanced uncompensated heart disease, uncompensated Type II Respiratory failure, severe grades of pulmonary hypertension
- pulmonary metastasis or lymphangitis carcinomatosis
- specific parenchymal pattern "honeycombing, probable UIP, diffuse end stage fibrosis, cystic lung diseases and advanced LAM and PLCH
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 forceps biopsyPatients undergo bronchoscopic transbronchial forceps biopsy to obtain lung tissue samples for histopathological diagnosis | Procedure or surgery | forceps biopsy |
| transbronchial cryobiopsyPatients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis | Procedure or surgery | Cryobiopsy |
| thoracoscopic lung biopsySurgical thoracoscopic procedure to obtain lung tissue samples | Procedure or surgery | Thoracoscopic biopsy |
Primary outcome
Diagnostic Yield of Different Lung Biopsy Techniques
Time frame: At time of biopsy procedure(day 0)
Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases
1 secondary outcome
Complication Rate of Lung Biopsy Techniques
Time frame: Within 30 days after the biopsy 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 25 Feb 2026.
- BackgroundSamarelli AV, Tonelli R, Marchioni A, et al. (2021) Fibrotic Idiopathic Interstitial Lung Disease: The Molecular and Cellular Key Players. Int J Mol Sci 22(16). https://doi.org/10.3390/ijms22168952 2. Raghu G, Collard HR, Egan JJ, et al. (2011) An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med 183(6):788-824.https://doi.org/10.1164/rccm.2009-040GL 3. Dhooria S, Sehgal IS, Aggarwal AN, et al. (2016) Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta Analysis. Respir Care 61(5):700-712. https://doi.org/10.4187/respcare.04488
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy
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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.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
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 forceps biopsy, transbronchial cryobiopsy and thoracoscopic lung biopsy in people with Interstitial Lung Diseases (ILD) and Hypersenstivity Pneumonitis, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 5 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 25 Feb 2026. 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 Egypt. 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 Different Lung Biopsy Techniques (time frame: At time of biopsy procedure(day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07432503, which also lists 1 linked publication.
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 25 Feb 2026.