TY - JOUR AU - Bousema, Jelle E. AU - Annema, Jouke T. AU - van der Heijden, Erik H. F. M. AU - Verhagen, Ad F. T. M. AU - Dijkgraaf, Marcel G. W. AU - van den Broek, Frank J. C. AU - Papen-Botterhuis, Nicole E. AU - Youssef-El Soud, Maggy AU - van Boven, Wim J. AU - Daniels, Johannes M.A. AU - Heineman, David J. AU - Zandbergen, Harmen R. AU - Brocken, Pepijn AU - Horn, Thirza AU - Steup, Willem H. AU - Braun, Jerry AU - Ramai, Rajen S. R. S. AU - Beck, Naomi AU - Barlo, Nicole P. AU - van Dorp, Martijn AU - Schreurs, W. Hermien AU - Dingemans, Anne-Marie C. AU - Maessen, Jos G. AU - Claessens, Niels J. M. AU - Lardenoije, Jan-Willem H. P. AU - Hiddinga, Birgitta I. AU - van de Wauwer, Caroline AU - van der Wekken, Anthonie J. AU - Hanselaar, Wessel E. AU - Kortekaas, Robert Th J. AU - Rijna, Herman AU - Bootsma, Gerben P. AU - Vissers, Yvonne L. J. AU - Veen, Eelco J. AU - van der Leest, Cor H. AU - Citgez, Emanuel AU - van Duyn, Eino B. AU - Marres, Geertruid M. H. AU - van Thiel, Eric R. AU - van Schil, Paul E. AU - van Meerbeeck, Jan P. AU - Smakman, Niels AU - van der Meer, Femke AU - Saboerali, Mohammed D. AU - Bosch, Anne Marie AU - de Jong, Wouter K. AU - van Rossem, Charles C. AU - Lie, W. Johan AU - Kouwenhoven, Ewout A. AU - Staal- van den Brekel, A. Jeske AU - Hanneman, Nike M. AU - Heller-Baan, Roxane AU - Noyez, Valentin J. J. M. AU - on behalf of the MEDIASTrial study group PY - 2021 DA - 2021/02/27 TI - MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan JO - Trials SP - 168 VL - 22 IS - 1 AB - Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC). Endosonography is recommended as initial staging technique, followed by confirmatory mediastinoscopy in case of negative N2 or N3 cytology after endosonography. Confirmatory mediastinoscopy however is under debate owing its limited additional diagnostic value, its associated morbidity and its delay in the start of lung cancer treatment. The MEDIASTrial examines whether confirmatory mediastinoscopy can be safely omitted after negative endosonography in mediastinal nodal staging of NSCLC. The present work is the proposed statistical analysis plan of the clinical consequences of omitting mediastinoscopy, which is submitted before closure of the MEDIASTrial and before knowledge of any results was done to enhance transparency of scientific behaviour. SN - 1745-6215 UR - https://doi.org/10.1186/s13063-021-05127-6 DO - 10.1186/s13063-021-05127-6 ID - Bousema2021 ER -