Transbronchial Cryobiopsy for the Diagnosis of Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Study.

Peripheral pulmonary lesions (PPLs) are increasingly detected by chest computed tomography, yet bronchoscopic diagnosis remains challenging for small and distal lesions. This prospective, single-center, randomized controlled study evaluated radial endobronchial ultrasound combined with a guide sheath (R-EBUS-GS)-assisted transbronchial cryobiopsy using a 1.1-mm ultrathin cryoprobe. Fifty patients with PPLs were randomized after successful R-EBUS-GS localization to either transbronchial cryobiopsy (TBCB) or conventional transbronchial lung biopsy with forceps (TBLB), with 25 patients in each group. The prespecified primary endpoint was pathological diagnostic yield. Pathological diagnostic yield was 84.0% in the TBCB group and 64.0% in the TBLB group; the difference was not statistically significant (p = 0.107). TBCB yielded a greater maximum total histologic tissue area than TBLB (14.6 &#xb1; 4.2 mm2 vs. 3.1 &#xb1; 0.9 mm2, p < 0.001) and was associated with a lower frequency of severe crush artifact (8.0% vs. 52.0%, p < 0.001). Grade 2 bleeding occurred in 32.0% and 24.0% of patients, respectively, and no Grade 3 bleeding occurred. One patient in the TBCB group developed pneumothorax and recovered with conservative treatment. These findings show that R-EBUS-GS-assisted 1.1-mm ultrathin cryobiopsy is technically feasible for PPL sampling and provides larger, better-preserved histologic specimens, while improvement in pathological diagnostic yield was not statistically demonstrated in this small randomized cohort.