Endosonography With or Without Confirmatory Mediastinoscopy for Resectable Lung Cancer:A Randomized Clinical Trial

PURPOSE:Resectable non-small-cell lung cancer (NSCLC) with a high probability of mediastinal nodal involvement requires mediastinal staging by endosonography and, in the absence of nodal metastases, confirmatory mediastinoscopy according to current guidelines. However, randomized data regarding immediate lung tumor resection after systematic endosonography versus additional confirmatory mediastinoscopy before resection are lacking.METHODS:Patients with (suspected) resectable NSCLC and an indication for mediastinal staging after negative systematic endosonography were randomly assigned to immediate lung tumor resection or confirmatory mediastinoscopy followed by tumor resection. The primary outcome in this noninferiority trial (noninferiority margin of 8% that previously showed to not compromise survival, Pnoninferior &lt;.0250) was the presence of unforeseen N2 disease after tumor resection with lymph node dissection. Secondary outcomes were 30-day major morbidity and mortality.RESULTS:Between July 17, 2017, and October 5, 2020, 360 patients were randomly assigned, 178 to immediate lung tumor resection (seven dropouts) and 182 to confirmatory mediastinoscopy first (seven dropouts before and six after mediastinoscopy). Mediastinoscopy detected metastases in 8.0% (14/175; 95% CI, 4.8 to 13.0) of patients. Unforeseen N2 rate after immediate resection (8.8%) was noninferior compared with mediastinoscopy first (7.7%) in both intention-to-treat (Δ, 1.03%; UL 95% CIΔ, 7.2%; Pnoninferior =.0144) and per-protocol analyses (Δ, 0.83%; UL 95% CIΔ, 7.3%; Pnoninferior =.0157). Major morbidity and 30-day mortality was 12.9% after immediate resection versus 15.4% after mediastinoscopy first (P =.4940).CONCLUSION:On the basis of our chosen noninferiority margin in the rate of unforeseen N2, confirmatory mediastinoscopy after negative systematic endosonography can be omitted in patients with resectable NSCLC and an indication for mediastinal staging.</p

Application of the Rome severity classification of COPD exacerbations in a real-world cohort of hospitalised patients

Background Recently, the Rome classification was proposed in which objective and readily measurable variables were integrated to mark exacerbations of COPD (ECOPD) severity. The aim of this study is to investigate the distribution of a real-world patient population with hospitalised ECOPD according to the current classification across the newly proposed severity classification. We assume that a significant proportion of hospitalised patients will have a mild or moderate event. Methods The Rome classification was applied to a cohort of 364 COPD patients hospitalised at the Department of Respiratory Medicine of Maastricht University Medical Center (MUMC) with a severe ECOPD. Differences in in-hospital, 30- and 90-day mortality were compared between mild, moderate and severe ECOPD according to the new classification. Moreover, data were stratified by the different severity classes and compared regarding general disease characteristics and clinical parameters. Results According to the Rome proposal, 52 (14.3%) patients had a mild ECOPD, 204 (56.0%) a moderate and 108 (29.7%) a severe ECOPD. In-hospital mortality in mild, moderate and severe events was 3.8%, 6.9% and 13.9%, respectively. Most clinical parameters indicated a significantly worse condition in patients classified in the severe group, compared to those in mild or moderate groups. Conclusion Most of the events, traditionally all classified as severe because of the hospitalisation, were classified as moderate, while almost 15% were mild. The results of this study provide insight into the heterogeneity of hospitalised ECOPD and show that the newly proposed Rome criteria can differentiate between events with different short-term mortality rates