Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy

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.

NCT Number	NCT07301697
Lead Sponsor	University Hospital, Strasbourg, France
Conditions	Mediastinal Lymphadenopathy, Mediastinal Lesions, Diffuse Interstitial Lung Diseases
Enrollment	30 participants
Start Date	2026-01-09
Primary Completion	2027-04-09 (estimated)
Study Completion	2027-04-19 (estimated)
Updated on ClinicalTrials.gov	2026-01-15