Abstract
Original language | English |
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Article number | 168 |
Journal | Trials |
Volume | 22 |
Issue number | 1 |
DOIs | |
Publication status | Published - 1 Dec 2021 |
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MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan. / on behalf of the MEDIASTrial study group.
In: Trials, Vol. 22, No. 1, 168, 01.12.2021.Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan
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
N1 - Funding Information: Beside the authors of this article the following steering group members and local investigators are member of the MEDIASTrial study group: Nicole E Papen-Botterhuis Academy, M?xima MC, Veldhoven, the Netherlands Maggy Youssef-El Soud Department of Pulmonary Medicine, M?xima MC, Veldhoven, the Netherlands Wim J van Boven Department of Cardiothoracic Surgery, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands Johannes MA Daniels Department of Pulmonary Medicine, Amsterdam University Medical Centres, VU University Medical Centre, Amsterdam, the Netherlands David J Heineman Department of Surgery, Amsterdam University Medical Centres, VU University Medical Centre, Amsterdam, the Netherlands Department of Cardiothoracic Surgery, Amsterdam University Medical Centres, VU University Medical Centre, Amsterdam, the Netherlands Harmen R Zandbergen Department of Cardiothoracic Surgery, Amsterdam University Medical Centres, VU University Medical Centre, Amsterdam, the Netherlands Pepijn Brocken Department of Pulmonary Medicine, HagaZiekenhuis, Den Haag, the Netherlands Thirza Horn Department of Surgery, HagaZiekenhuis, Den Haag, the Netherlands Willem H Steup Department of Surgery, HagaZiekenhuis, Den Haag, the Netherlands Jerry Braun Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands Rajen SRS Ramai Department of Pulmonary Medicine, Leiden University Medical Centre, Leiden, the Netherlands Naomi Beck Dutch Institute for Clinical Auditing, Leiden, the Netherlands Nicole P Barlo Department of Pulmonary Medicine, Northwest Clinics, Alkmaar, the Netherlands Martijn van Dorp Department of Surgery, Northwest Clinics, Alkmaar, the Netherlands W Hermien Schreurs Department of Surgery, Northwest Clinics, Alkmaar, the Netherlands Anne-Marie C Dingemans Department of Pulmonary Medicine, Maastricht University Medical Centre, Maastricht, NL Jos G Maessen Department of Cardiothoracic Surgery, Maastricht University Medical Centre, Maastricht, NL Niels JM Claessens Department of Pulmonary Medicine, Rijnstate Hospital, Arnhem, the Netherlands Jan-Willem HP Lardenoije Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands Birgitta I Hiddinga Department of Pulmonary Medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands Caroline van de Wauwer Department of Cardiothoracic Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands Anthonie J van der Wekken Department of Pulmonary Medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands Wessel E Hanselaar Department of Pulmonary Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, the Netherlands Robert ThJ Kortekaas Department of Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, the Netherlands Martin P Bard Department of Pulmonary Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands Herman Rijna Department of Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands Gerben P Bootsma Department of Pulmonary Medicine, Zuyderland Medical Centre, Heerlen, the Netherlands Yvonne LJ Vissers Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands Eelco J Veen Department of Surgery, Amphia Hospital, Breda, the Netherlands Cor H van der Leest Department of Pulmonary Medicine, Amphia Hospital, Breda, the Netherlands Emanuel Citgez Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands Eino B van Duyn Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands Geertruid MH Marres Department of Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands Eric R van Thiel Department of Pulmonary Medicine, Albert Schweitzer Hospital, Dordrecht, the Netherlands Paul E van Schil Department of Thoracic and Vascular Surgery, Antwerp University Hospital, Antwerp, Belgium Jan P van Meerbeeck Department of Pulmonary Medicine, Antwerp University Hospital, Antwerp, Belgium Niels Smakman Department of Surgery, Diakonessenhuis, Utrecht, the Netherlands Femke van der Meer Department of Pulmonary Medicine, Diakonessenhuis, Utrecht, the Netherlands Mohammed D Saboerali Department of Pulmonary Medicine, Beatrixziekenhuis, Gorinchem, the Netherlands Anne Marie Bosch Department of Surgery, Hospital Gelderse Vallei, Ede, the Netherlands Wouter K de Jong Department of Pulmonary Medicine, Hospital Gelderse Vallei, Ede, the Netherlands Charles C van Rossem Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands W Johan Lie Department of Pulmonary Medicine, Maasstad Hospital, Rotterdam, the Netherlands Ewout A Kouwenhoven Department of Surgery, Hospital Group Twente (ZGT), Almelo, the Netherlands A Jeske Staal ? van den Brekel Department of Pulmonary Medicine, Hospital Group Twente (ZGT), Almelo, the Netherlands Nike M Hanneman Department of Surgery, Ikazia Hospital, Rotterdam, the Netherlands Roxane Heller ? Baan Department of Pulmonary Medicine, Ikazia Hospital, Rotterdam, the Netherlands Valentin JJM Noyez Department of Vascular and Thoracic Surgery, Sint-Maarten General Hospital, Mechelen The MEDIASTrial is registered at the Netherlands Trial Register on July 6, 2017 (NL6344/NTR6528), www.trialregister.nl/trial/6344. SAP history Version 1.0 Submitted to Trials on September 24, 2020 Sent back on October 14, 2020, with request to change the title so that it is in the format ?[title of original protocol article]: a Statistical Analysis Plan Version 1.1 Submitted to Trials on October 16, 2020 Sent back on January 19, 2021, with comments for improvement: addition of the reporting guideline for SAPs checklist, identify the responsible senior statistician and the clinical chief investigator, explanation of the non-inferiority threshold and describing the planned subgroup analyses. Version 1.2 Submitted to Trials on February 8, 2021 Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Background: 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. Methods: The primary outcome measure of this non-inferiority trial will be unforeseen N2 disease resulting from lobe-specific mediastinal lymph node dissection. For non-inferiority, the upper limit of the 95% confidence interval of the unforeseen N2 rate in the group without mediastinoscopy should not exceed 14.3% in order to probably have no negative impact on survival. Since this is a non-inferiority trial, both an intention to treat (ITT) and a per protocol (PP) analyses will be done. The ITT and the PP analyses should both indicate non-inferiority before the diagnostic strategy omitting mediastinoscopy will be interpreted as non-inferior to the strategy with mediastinoscopy. Secondary outcome measures include 30-day major morbidity and mortality, the total number of days of hospital care, overall and disease free 2-year survival, generic and disease-specific health related quality of life and cost-effectiveness and cost-utility of staging strategies with and without mediastinoscopy. Discussion: The MEDIASTrial will determine if confirmatory mediastinoscopy can be omitted after tumour negative systematic endosonography in invasive mediastinal staging of patients with resectable NSCLC. Trial registration: Netherlands Trial Register NL6344/NTR6528. Registered on 2017 July 06.
AB - Background: 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. Methods: The primary outcome measure of this non-inferiority trial will be unforeseen N2 disease resulting from lobe-specific mediastinal lymph node dissection. For non-inferiority, the upper limit of the 95% confidence interval of the unforeseen N2 rate in the group without mediastinoscopy should not exceed 14.3% in order to probably have no negative impact on survival. Since this is a non-inferiority trial, both an intention to treat (ITT) and a per protocol (PP) analyses will be done. The ITT and the PP analyses should both indicate non-inferiority before the diagnostic strategy omitting mediastinoscopy will be interpreted as non-inferior to the strategy with mediastinoscopy. Secondary outcome measures include 30-day major morbidity and mortality, the total number of days of hospital care, overall and disease free 2-year survival, generic and disease-specific health related quality of life and cost-effectiveness and cost-utility of staging strategies with and without mediastinoscopy. Discussion: The MEDIASTrial will determine if confirmatory mediastinoscopy can be omitted after tumour negative systematic endosonography in invasive mediastinal staging of patients with resectable NSCLC. Trial registration: Netherlands Trial Register NL6344/NTR6528. Registered on 2017 July 06.
KW - Endosonography
KW - Mediastinal nodal staging
KW - Mediastinoscopy
KW - Non-small cell lung carcinoma
KW - Statistical analysis plan
KW - Thoracic surgery
UR - http://www.scopus.com/inward/record.url?scp=85101933595&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05127-6
DO - 10.1186/s13063-021-05127-6
M3 - Article
C2 - 33639999
VL - 22
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 168
ER -