The addition of radial endobronchial ultrasound to electromagnetic navigation bronchoscopy: the NEBULA study—a randomized controlled trial

Background Bronchoscopic biopsies are a valuable tool for diagnosing small peripheral lung lesions suspected of cancer. Electromagnetic Navigation Bronchoscopy (ENB) has been developed to guide the bronchoscopist to the lesion and Radial Endobronchial Ultrasound (rEBUS) to confirm the presence lesion once reached. The combination of modalities might improve the diagnostic yield; however, only a few studies with diverting results have been published. Objective To investigate whether the combination of rEBUS and ENB is superior to ENB alone for diagnosing peripheral lung lesions suspected of lung cancer in a pragmatic study setting representing the daily clinical practices and challenges. Methods The study was conducted according to CONSORT guidelines. All patients were randomized for either ENB or ENB+rEBUS. The reference test was either a final histopathologic diagnosis or determined by six months of CT surveillance. Analyses were performed using intention-to-treat, with only procedures with a definitive diagnosis categorized as “diagnostic.” Results Of 200 patients included from four centers, 183 were randomized and included in the final analyses. There was no difference in diagnostic yield between the two groups, (43.8 versus 45.7); nor did we find any difference in malignant yield or adverse events. Conclusion ENB+rEBUS is a safe and well tolerated procedure, but not superior to ENB alone.