Actively Recruiting
Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
Led by University Hospital, Strasbourg, France · Updated on 2026-01-15
30
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone or are eligible for cryobiopsy according to national or international recommendations or after a failed first diagnostic test with collegial discussion
- Procedure performed in the bronchial endoscopy department of Strasbourg University Hospitals
- For diffuse interstitial lung diseases, decision for transbronchial cryobiopsy made after multidisciplinary consultation when diagnosis is unclear and surgical lung biopsy is not suitable or as an alternative
- For lymph node puncture (EBUS-cryobiopsy), performed after multidisciplinary discussion as a second- or third-line procedure following diagnostic failure or as a first-line procedure alongside EBUS-TBNA if lymphoma is strongly suspected
- For retrospective analysis, patients who underwent cryobiopsy or CT-guided lung biopsy since July 2024 for ILD diagnosis or suspected pulmonary neoplasm
You will not qualify if you...
- Patients under 18 years of age
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship, or legal protection
- Patients at increased bleeding risk: anticoagulants not stopped 24 hours prior, direct oral anticoagulants not stopped 5 days prior, INR > 1.5 for those on VKAs and heparin, dual antiplatelet therapy, platelet count below 50 G/L
- Oxygen saturation below 90% on oxygen therapy with flow above 2 L/min
- Severe heart disease including unstable angina, myocardial infarction, decompensated heart failure
- Known pulmonary hypertension with systolic arterial pressure above 50 mmHg on echocardiography
- Inability to provide informed consent due to emergency or comprehension difficulties
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pulmonology Department - NHC Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
M
Michele PORZIO, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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