• Jelle E Bousema, Dijkgraaf Marcel G W MGW University of Amsterdam, Amsterdam, the Netherlands. Clinical Research Unit, Ac, Nicole E Papen-Botterhuis, Hermien W Schreurs, Jos G Maessen, Erik H van der Heijden, Willem H Steup, Jerry Braun, Valentin J J M Noyez, Fieke Hoeijmakers, Naomi Beck, Martijn van Dorp, Claessens Niels J M NJM Department of Pulmonary Medicine, Rijnstate ziekenhuis, Arnhem, the Netherlands., Birgitta I Hiddinga, Daniels Johannes M A JMA Department of Pulmonary Medicine, VU University Medical Center, Amsterdam, the Netherlands., David J Heineman, Harmen R Zandbergen, Verhagen Ad F T M AFTM Department of Cardiothoracic Surgery, Radboud University Medical Center, Nijmegen, the Netherlands., Paul E van Schil, Jouke T Annema, Frank J C van den Broek, and MEDIASTrial study group.
• Department of Surgery, Máxima Medical Center, PO BOX 7777, 5500 MB, Veldhoven, the Netherlands.
• Bmc Surg. 2018 May 18; 18 (1): 27.

BackgroundIn case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings. We hypothesize that omitting mediastinoscopy after negative endosonography in mediastinal staging of NSCLC does not result in an unacceptable percentage of unforeseen N2 disease at surgical resection. In addition, omitting mediastinoscopy comprises no extra waiting time until definite surgery, omits one extra general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life. The aim of this study is to compare the cost-effectiveness and cost-utility of mediastinal staging strategies including and excluding mediastinoscopy.Methods/DesignThis study is a multicenter parallel randomized non-inferiority trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in 360 patients with suspected resectable NSCLC. Patients are eligible for inclusion when they underwent systematic endosonography to evaluate mediastinal lymph nodes including tissue sampling with negative endosonography results. Patients will not be eligible for inclusion when PET/CT demonstrates 'bulky N2-N3' disease or the combination of a highly suspicious as well as irresectable mediastinal lymph node. Primary outcome measure for non-inferiority is the proportion of patients with unforeseen N2 disease at surgery. Secondary outcome measures are hospitalization, morbidity, overall 2-year survival, quality of life, cost-effectiveness and cost-utility. Patients will be followed up 2 years after start of treatment.DiscussionResults of the MEDIASTrial will have immediate impact on national and international guidelines, which are accessible to public, possibly reducing mediastinoscopy as a commonly performed invasive procedure for NSCLC staging and diminishing variation in clinical practice.Trial RegistrationThe trial is registered at the Netherlands Trial Register on July 6th, 2017 ( NTR 6528 ).

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