Introduction: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the most widely-accepted approach for mediastinal disease; however, its diagnostic utility could be limited by the insufficiency of intact samples. We and others have priorly shown that additional transbronchial forceps biopsy and cryobiopsy, which can offer larger amounts of intact mediastinal tissues, improve the overall diagnostic yield of EBUS-TBNA.

Aims and Objectives: We aimed to compare the added value of cryobiopsy with forceps biopsy for the diagnosis of mediastinal lesion.

Methods: Patients with at least 1 mediastinal lesion were enrolled. After 4 passes of TBNA, 3 forceps biopsies and 1 cryobiopsy were conducted in a randomised order. Efficacy and safety were assessed.

Results: 154 patients (106 males and 48 females; mean age 57 years) were included in this prospective, randomised trial. The overall diagnostic yield of EBUS-TBNA plus cryobiopsy was 91.6%, which was similar with that of EBUS-TBNA plus forceps biopsy (85.7%, p=0.11). Both forceps biopsy and cryobiopsy were able to establish a diagnosis in 106 (70.1%) patients. 26 additional cases nondiagnostic by forceps biopsy were successfully diagnosed by cryobiopsy, whereas in 3 patients, the diagnosis were only established by forceps biopsy, resulting in a overall diagnostic yield of 70.8% for forceps biopsy and 85.7% for cryobiopsy (p=0.001). The time needed for 1 cryobiopsy was significantly shorter than that of 3 forceps biopsies. We observed 2 cases of pneumothorax.

Conclusions: Transbronchial mediastinal cryobiopsy might be an ideal complementary biopsy tool to standard needle aspiration.