Mediastinal LymphadenopathySeReCryoNCT07301697
Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
A study testing performance of a transbronchial cryobiopsy or EBUS-cryobiopsy in people with Mediastinal Lymphadenopathy and Mediastinal Lesions, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Transbronchial cryobiopsy is a relatively recent technique, increasingly used for the diagnosis of various respiratory diseases, including neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Mediastinal Lesions, Diffuse Interstitial Lung Diseases
- What is being tested?
- performance of a transbronchial cryobiopsy or EBUS-cryobiopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2026to 19 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who have undergone, or are eligible for, a cryobiopsy according to national or international recommendations, or after failure of a first diagnostic test followed by a collegial discussion regarding the indication for cryobiopsy.
- Procedure performed within the bronchial endoscopy department of the New Civil Hospital of the University Hospitals of Strasbourg.
- For diffuse interstitial lung diseases: decision to perform a transbronchial cryobiopsy after case review in a multidisciplinary consultation meeting for patients whose specific type of ILD could not be determined with thoracic imaging and biological tests alone, for patients not eligible for surgical lung biopsy (SLB) due to the severity of their respiratory condition, or as an alternative to SLB (according to the recommendations of the European Respiratory Society).
- For lymph node puncture (EBUS-cryobiopsy): after discussing the case in a multidisciplinary concentration meeting, in patients with a lesion and/or mediastinal adenopathy, as a second- or third-line procedure, following the diagnostic failure of bronchial fibroscopy and/or transbronchial needle aspiration guided by endobronchial ultrasound (EBUS-TBNA). For patients with a strong suspicion of lymphoma, EBUS-cryobiopsy can be performed as a first-line procedure in parallel with EBUS-TBNA (which is systematically performed during the same procedure) in order to reduce the diagnostic delay.
- For the retrospective analysis: all patients who underwent a cryobiopsy, and those who had a CT-guided lung biopsy for diagnostic assessment of an ILD or evaluation of suspected pulmonary neoplasm, since July 2024.
Who cannot join
- - Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, or legal protection.
- Patients at increased risk of bleeding: patients on anticoagulants not stopped for 24 hours, or on direct oral anticoagulants not stopped for 5 days, or with INR > 1.5 for patients on VKAs and heparin. Patients on dual antiplatelet therapy. Platelet count below 50 G/L.
- Saturation below 90% on oxygen therapy with a maximum allowable flow of 2 L/min.
- Pre-existing severe heart disease: unstable angina, myocardial infarction, decompensated heart failure.
- Known pulmonary hypertension with systolic pulmonary arterial pressure above 50 mmHg on transthoracic echocardiography.
- Inability to provide the subject with informed information (emergency situation, subject has difficulty understanding, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pulmonology Department - NHC Strasbourg
Strasbourg
About this study
Transbronchial cryobiopsy is a relatively recent technique, increasingly used for the diagnosis of various respiratory diseases, including neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is included in European recommendations for the diagnosis of interstitial lung diseases. EBUS-cryobiopsy, on the other hand, has proven useful in the evaluation of lesions and mediastinal lymphadenopathy. Several studies have compared this method to the reference technique, EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration), and the results suggest a higher diagnostic yield for cryobiopsy, particularly for detecting benign lesions and lymphomas. However, to date, no French recommendation has yet been published regarding the precise role of this examination in the management of mediastinal lesions. Since July 2024, transbronchial cryobiopsies and EBUS-cryobiopsies have been routinely performed in the thoracic endoscopy department of Strasbourg University Hospital by an experienced team of interventional pulmonologists. The indications are those described above, after approval in a multidisciplinary consultation meeting. The number of prospective studies on cryobiopsies is currently limited. With this study, the investigators aim to carry out work intended to complement the current data on the profitability and safety of using cryobiopsies in the center, based on their results obtained since July 2024, as well as through prospective data collection from procedures performed over a one-year period. In addition to a prospective component, this study has the strong point of evaluating the procedure conducted by a limited number of experienced operators, thereby reducing the risk of significant inter-operator variability, as has been observed in previous studies. Finally, this is the first French study on the subject. The investigators hypothesize that performing cryobiopsies in a large university hospital by experienced operators allows for obtaining satisfactory diagnostic results under good safety conditions.
- Being tested
- performance of a transbronchial cryobiopsy or EBUS-cryobiopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance of a transbronchial cryobiopsy or EBUS-cryobiopsyDiagnostic test
Transbronchial cryobiopsy is a relatively recent technique that is increasingly used for the diagnosis of various respiratory pathologies, notably neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is integrated into European recommendations for the diagnosis of interstitial lung diseases. EBUS-cryobiopsy, on the other hand, has proven useful in the exploration of lesions and mediastinal lymphadenopathies. Several studies have compared this method to the reference technique, EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration), and the results suggest a superior diagnostic yield of cryobiopsy, particularly for the detection of benign lesions and lymphomas.
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent a cryobiopsy | Experimental | performing a transbronchial cryobiopsy or EBUS-cryobiopsy on a patient with an evaluation for diffuse interstitial lung disease Receives: Diagnostic Test: performance of a transbronchial cryobiopsy or EBUS-cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the diagnostic performance of transbronchial cryobiopsy and EBUS cryobiopsy in both indications
Determination of the exact diagnosis of ILD for patients with diffuse interstitial pneumonia confirmation of the diagnosis of the lesion (pulmonary neoplasm, lymphoma, sarcoidosis, etc.) in patients with mediastinal lesions and mediastinal lymphadenopathy
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start9 Jan 2026
- Primary completion9 Apr 2027 (estimated)
- Study completion19 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele PORZIO, Doctor, Principal investigator, Pulmonology Department - Nouvel Hôpital Civil - HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301697
- Sponsor's protocol ID
- 9624
- Other IDs
- 2025-A01681-48
- Acronym
- SeReCryo
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 15 Jan 2026
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
- ClinicalTrials.gov ID
- NCT07301697
- Acronym / sponsor ID
- SeReCryo / 9624
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 19 Apr 2027 (estimated)
- First posted
- 24 Dec 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.
Transbronchial cryobiopsy is a relatively recent technique, increasingly used for the diagnosis of various respiratory diseases, including neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is included in European recommendations for the diagnosis of interstitial lung diseases. EBUS-cryobiopsy, on the other hand, has proven useful in the evaluation of lesions and mediastinal lymphadenopathy. Several studies have compared this method to the reference technique, EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration), and the results suggest a higher diagnostic yield for cryobiopsy, particularly for detecting benign lesions and lymphomas. However, to date, no French recommendation has yet been published regarding the precise role of this examination in the management of mediastinal lesions. Since July 2024, transbronchial cryobiopsies and EBUS-cryobiopsies have been routinely performed in the thoracic endoscopy department of Strasbourg University Hospital by an experienced team of interventional pulmonologists. The indications are those described above, after approval in a multidisciplinary consultation meeting. The number of prospective studies on cryobiopsies is currently limited. With this study, the investigators aim to carry out work intended to complement the current data on the profitability and safety of using cryobiopsies in the center, based on their results obtained since July 2024, as well as through prospective data collection from procedures performed over a one-year period. In addition to a prospective component, this study has the strong point of evaluating the procedure conducted by a limited number of experienced operators, thereby reducing the risk of significant inter-operator variability, as has been observed in previous studies. Finally, this is the first French study on the subject. The investigators hypothesize that performing cryobiopsies in a large university hospital by experienced operators allows for obtaining satisfactory diagnostic results under good safety conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent a cryobiopsy | Experimental | Diagnostic Test: performance of a transbronchial cryobiopsy or EBUS-cryobiopsyperforming a transbronchial cryobiopsy or EBUS-cryobiopsy on a patient with an evaluation for diffuse interstitial lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients who have undergone, or are eligible for, a cryobiopsy according to national or international recommendations, or after failure of a first diagnostic test followed by a collegial discussion regarding the indication for cryobiopsy.
- Procedure performed within the bronchial endoscopy department of the New Civil Hospital of the University Hospitals of Strasbourg.
- For diffuse interstitial lung diseases: decision to perform a transbronchial cryobiopsy after case review in a multidisciplinary consultation meeting for patients whose specific type of ILD could not be determined with thoracic imaging and biological tests alone, for patients not eligible for surgical lung biopsy (SLB) due to the severity of their respiratory condition, or as an alternative to SLB (according to the recommendations of the European Respiratory Society).
- For lymph node puncture (EBUS-cryobiopsy): after discussing the case in a multidisciplinary concentration meeting, in patients with a lesion and/or mediastinal adenopathy, as a second- or third-line procedure, following the diagnostic failure of bronchial fibroscopy and/or transbronchial needle aspiration guided by endobronchial ultrasound (EBUS-TBNA). For patients with a strong suspicion of lymphoma, EBUS-cryobiopsy can be performed as a first-line procedure in parallel with EBUS-TBNA (which is systematically performed during the same procedure) in order to reduce the diagnostic delay.
- For the retrospective analysis: all patients who underwent a cryobiopsy, and those who had a CT-guided lung biopsy for diagnostic assessment of an ILD or evaluation of suspected pulmonary neoplasm, since July 2024.
Key exclusion criteria (8 listed)
- - Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, or legal protection.
- Patients at increased risk of bleeding: patients on anticoagulants not stopped for 24 hours, or on direct oral anticoagulants not stopped for 5 days, or with INR > 1.5 for patients on VKAs and heparin. Patients on dual antiplatelet therapy. Platelet count below 50 G/L.
- Saturation below 90% on oxygen therapy with a maximum allowable flow of 2 L/min.
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 |
|---|---|---|
| performance of a transbronchial cryobiopsy or EBUS-cryobiopsyTransbronchial cryobiopsy is a relatively recent technique that is increasingly used for the diagnosis of various respiratory pathologies, notably neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is integrated into European recommendations for the diagnosis of interstitial lung diseases. EBUS-cryobiopsy, on the other hand, has proven useful in the exploration of lesions and mediastinal lymphadenopathies. Several studies have compared this method to the reference technique, EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration), and the results suggest a superior diagnostic yield of cryobiopsy, particularly for the detection of benign lesions and lymphomas. | Diagnostic test | patients who underwent a cryobiopsy |
Primary outcome
Assess the diagnostic performance of transbronchial cryobiopsy and EBUS cryobiopsy in both indications
Time frame: immediately after the intervention
Determination of the exact diagnosis of ILD for patients with diffuse interstitial pneumonia confirmation of the diagnosis of the lesion (pulmonary neoplasm, lymphoma, sarcoidosis, etc.) in patients with mediastinal lesions and mediastinal lymphadenopathy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
Michele PORZIO, Doctor principal investigator
Pulmonology Department - Nouvel Hôpital Civil - HUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performance of a transbronchial cryobiopsy or EBUS-cryobiopsy in people with Mediastinal Lymphadenopathy and Mediastinal Lesions, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Jan 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele PORZIO, Doctor (03 88 24 04 03, michele.porzio@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the diagnostic performance of transbronchial cryobiopsy and EBUS cryobiopsy in both indications (time frame: immediately after the intervention). 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 15 Jan 2026.