B59-04 Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration for Diagnosing Sarcoidosis: A Randomized Controlled Trial

Background Endobronchial ultrasound (EBUS)-guided transbronchial mediastinal cryobiopsy (TBMC) has potential superiority compared with EBUS-guided transbronchial needle aspiration (TBNA) in the diagnosis of patients with intrathoracic sarcoidosis. However, high-quality clinical evidence is lacking. Objective The aim of this study was to compare the efficacy and safety of EBUS-TBMC and EBUS-TBNA in diagnosing patients with intrathoracic sarcoidosis. Methods A multicentre randomized controlled trial was conducted in patients with suspected stage I/II sarcoidosis. Following identification of the mediastinal lesion via EBUS, TBNA and TBMC were sequentially performed in a randomized order. The granuloma detection rate was the primary outcome. The final diagnosis was based on pathology results and clinical follow-up at 6 months after randomization. Results A total of 128 patients with suspected stage I/II sarcoidosis were recruited for this study. Among them, 116 patients were diagnosed with sarcoidosis at 6 months after randomization. The granuloma detection rate was 89.8% (95% confidence interval [CI]: 83.3-94.5) for EBUS-TBMC and 78.1% (95% CI: 70.0-84.9) for EBUS-TBNA, and the difference was significant (p < 0.001). The histological quality of the EBUS-TBMC samples was superior to that of the EBUS-TBNA samples (p < 0.001). Only one case of pneumothorax was detected by chest radiography, which resolved spontaneously without the need for drainage or other interventions. Conclusions Compared with EBUS-TBNA, EBUS-TBMC had superior granuloma detection rate and histological quality of samples with acceptable safety in patients suspected with stage I/II sarcoidosis. This abstract is funded by: This work was financially supported by the National High-Level Hospital Clinical Research Funding (2025-NHLHCRF-JBGS-A-WZ-14), Noncommunicable Chronic Title Page Diseases-National Science and Technology Major Project (2024ZD0528900 to G Hou, 2024ZD0528902 to G Hou), and CAMS Innovation Fund for Medical Sciences (CIFMS, No.2022-I2M-1-025).