The diagnostic efficiency and safety of transbronchial lung cryobiopsy using 1.1-mm cryoprobe in diagnosing interstitial lung disease

Abstract Introduction: Transbronchial lung cryobiopsy (TBLC) is increasingly used to diagnose interstitial lung disease (ILD). The 1.1-mm cryoprobe has recently been available in clinical practice. The diagnostic yield and safety of TBLC using a 1.1-mm cryoprobe need to be confirmed. Methods: A prospective, randomized controlled trial was conducted in patients with suspected ILD and randomly assigned to 1.1-mm and 1.9-mm cryoprobe groups. The primary outcome was the diagnostic yield of multidisciplinary discussion (MDD). Secondary outcomes were sample quality and incidence of complications. The tension and stress effects during TBLC onto the target lobe caused by 1.1-mm, 1.9-mm, and 2.4 mm cryoprobes were also evaluated using finite element analysis. Results: A total of 224 patients were enrolled. No significant differences were observed in the diagnostic yield (80.4% vs. 79.5%, p =0.845) and sample quality scores (5.73±0.64 vs. 5.66±0.77; p =0.324) between the 1.9-mm cryoprobe group and 1.1-mm cryoprobe group. The average surface areas of samples in 1.1-mm cryoprobe group were smaller, while no difference in sample weights was observed. A decreased incidence of moderate bleeding was found in the 1.1-mm cryoprobe group (17.0% vs. 6.2%, p =0.027), while the incidence of pneumothorax was higher in the 1.1-mm cryoprobe group but did not reach statistical significance (1.8% vs. 7.1%, p =0.070). In finite element analysis, the 1.1-mm cryoprobe required the largest tension and produced the largest stress. Conclusion: Compared with a 1.9-mm cryoprobe, there was no difference in specimen quality or diagnostic rate but smaller sample size with a 1.1-mm cryoprobe. Trail registration: clinicaltrials.gov identifier NCT04047667; registered August 4, 2019