Abstract
BACKGROUND: Transbronchial lung biopsy is routinely performed to identify acute cellular rejection (ACR) in lung transplant recipients (LTRs). This trial evaluates the clinical value of forceps and cryobiopsies versus cryobiopsies as a standalone diagnostic tool. METHODS: In this randomized trial, LTRs were randomly assigned to receive either 2 cryobiopsies (cryobiopsy group) or a combination of 5 forceps- and 2 cryobiopsies (combined group). The primary outcome was the diagnostic yield to detect ACR; the secondary outcome was the incidence of ACR. We conducted a paired, intraindividual comparison in the combined group alongside interindividual comparisons. RESULTS: A total of 80 LTRs were randomly assigned to the cryobiopsy group (n = 40) or the combined group (n = 40) with 90 and 87 procedures performed, respectively. The diagnostic yield for ACR in the cryobiopsy group was similar to the combined group (95.6% vs 97.7%, p = 0.430). The sole use of cryobiopsies did not lead to a lower ACR incidence compared to the combined group (10% vs 17.2%, risk ratio 2.21 [95% confidence interval (CI) 0.67-7.29]; p = 0.190). Adverse events did not differ between the 2 groups (60.9% vs 57.5%, p = 0.655). The pneumothorax rate was overall 1.7%. There were no deaths or occurrences of severe bleeding. CONCLUSIONS: Cryobiopsies did not detect lower ACR than the combined group and can be used as primary and standalone diagnostic tools for histologic assessment of ACR without requiring forceps biopsies.