Cryobiopsy during bronchial endoscopy: safety and how well it works
Official title: Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
Run by University Hospital, Strasbourg, France · NCT07301697 · Data updated 2026-11-12
This project tries cryobiopsy during bronchial endoscopy to see if it is safe and provides better diagnostic tissue for people with mediastinal lesions, enlarged lymph nodes, or diffuse interstitial lung disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | January 9, 2026 |
| Main results expected | April 9, 2027 |
| Study ends | April 19, 2027 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07301697 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with mediastinal lesions, mediastinal lymphadenopathy, or suspected diffuse interstitial lung disease who are judged eligible for cryobiopsy by multidisciplinary review and who will undergo the procedure at the Strasbourg bronchial endoscopy department.
✕Probably not a fit
Patients who cannot undergo bronchoscopy, who have prohibitive bleeding or respiratory risk, or who already have a clear diagnosis from less invasive tests are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol records outcomes after performing transbronchial cryobiopsy or EBUS-cryobiopsy in patients managed at the New Civil Hospital, University Hospitals of Strasbourg. Procedures are done when recommended by national/international guidance or after multidisciplinary case review, including patients with suspected diffuse ILD who are not candidates for surgical lung biopsy. The study will capture diagnostic yield, procedural performance details, and safety events to define a local safety and performance profile. Findings will be compared to existing literature that has contrasted cryobiopsy with EBUS-TBNA, particularly for benign lesions and lymphomas.
Why it matters
Potential benefit: If successful, cryobiopsy could provide safer and more accurate tissue samples, reducing the need for surgical lung biopsy and improving diagnosis of mediastinal lesions and ILD.
How similar studies have gone: Prior studies comparing cryobiopsy to EBUS-TBNA have suggested a higher diagnostic yield for cryobiopsy, especially for benign lesions and lymphomas, though national French guidance is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * \- 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.)
Where it's running
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Pulmonology Department - NHC Strasbourg
Strasbourg, France Recruiting
Study contacts
- Principal investigator: Michele PORZIO, Doctor — Pulmonology Department - Nouvel Hôpital Civil - HUS
- Study coordinator: Michele PORZIO, Doctor
- Email: michele.porzio@chru-strasbourg.fr
- Phone: 03 88 24 04 03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.