TY - JOUR
T1 - MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial)
T2 - Study protocol of a multicenter randomised controlled trial
AU - Bousema, Jelle E.
AU - Dijkgraaf, Marcel G.W.
AU - Papen-Botterhuis, Nicole E.
AU - Schreurs, Hermien W.
AU - Maessen, Jos G.
AU - Van Der Heijden, Erik H.
AU - Steup, Willem H.
AU - Braun, Jerry
AU - Noyez, Valentin J.J.M.
AU - Hoeijmakers, Fieke
AU - Beck, Naomi
AU - Van Dorp, Martijn
AU - Claessens, Niels J.M.
AU - Hiddinga, Birgitta I.
AU - Daniels, Johannes M.A.
AU - Heineman, David J.
AU - Zandbergen, Harmen R.
AU - Verhagen, Ad F.T.M.
AU - Van Schil, Paul E.
AU - Annema, Jouke T.
AU - Van Den Broek, Frank J.C.
AU - Youssef-El Soud, Maggy
AU - Van Boven, Wim J.
AU - Horn, Thirza
AU - Brocken, Pepijn
AU - Ramai, Rajan R.S.
AU - Barlo, Nicole P.
AU - Dingemans, Anne Marie C.
AU - Lardenoije, Jan Willem
AU - Van Der Wekken, Anthonie J.
AU - Van De Wauwer, Caroline
AU - Kortekaas, Robert Th J.
AU - Hanselaar, Wessel E.
AU - Rijna, Herman
AU - Bard, Martin P.
AU - Van Vollenhoven, Femke H.M.
AU - Murrmann, Gabi B.
AU - Bootsma, Gerben P.
AU - Vissers, Yvonne
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 - Zhang, Xiang H.
AU - Barendregt, Wout B.
AU - Janssen, Julius P.
AU - Smakman, Niels
AU - Van Der Meer, Femke
N1 - Funding Information:
This study is already peer reviewed by national and international experts as well as funded by ZonMw (project number 843004109) and The Dutch Cancer Society (project number 11313).
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/5/18
Y1 - 2018/5/18
N2 - Background: In 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/design: This 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. Discussion: Results 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 registration: The trial is registered at the Netherlands Trial Register on July 6th, 2017 (NTR 6528).
AB - Background: In 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/design: This 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. Discussion: Results 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 registration: The trial is registered at the Netherlands Trial Register on July 6th, 2017 (NTR 6528).
UR - http://www.scopus.com/inward/record.url?scp=85047203268&partnerID=8YFLogxK
U2 - 10.1186/s12893-018-0359-6
DO - 10.1186/s12893-018-0359-6
M3 - Article
C2 - 29776444
AN - SCOPUS:85047203268
SN - 1471-2482
VL - 18
JO - BMC Surgery
JF - BMC Surgery
IS - 1
M1 - 27
ER -
