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MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): study protocol of a multicenter randomised controlled trial.
Bousema, Jelle E; Dijkgraaf, Marcel G W; Papen-Botterhuis, Nicole E; Schreurs, Hermien W; Maessen, Jos G; van der Heijden, Erik H; Steup, Willem H; Braun, Jerry; Noyez, Valentin J J M; Hoeijmakers, Fieke; Beck, Naomi; van Dorp, Martijn; Claessens, Niels J M; Hiddinga, Birgitta I; Daniels, Johannes M A; Heineman, David J; Zandbergen, Harmen R; Verhagen, Ad F T M; van Schil, Paul E; Annema, Jouke T; van den Broek, Frank J C.
  • Bousema JE; Department of Surgery, Máxima Medical Center, PO BOX 7777, 5500 MB, Veldhoven, the Netherlands.
  • Dijkgraaf MGW; University of Amsterdam, Amsterdam, the Netherlands.
  • Papen-Botterhuis NE; University of Amsterdam, Amsterdam, the Netherlands.
  • Schreurs HW; Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands.
  • Maessen JG; Department of Surgery, Máxima Medical Center, PO BOX 7777, 5500 MB, Veldhoven, the Netherlands.
  • van der Heijden EH; Department of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.
  • Steup WH; Department of Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.
  • Braun J; Department of Pulmonary Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.
  • Noyez VJJM; Department of Surgery, HagaZiekenhuis, Den Haag, the Netherlands.
  • Hoeijmakers F; Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, the Netherlands.
  • Beck N; Department of Surgery, KU Leuven, Leuven, Belgium.
  • van Dorp M; Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
  • Claessens NJM; Dutch Institute for Clinical Auditing, Leiden, the Netherlands.
  • Hiddinga BI; Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
  • Daniels JMA; Dutch Institute for Clinical Auditing, Leiden, the Netherlands.
  • Heineman DJ; Department of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.
  • Zandbergen HR; Department of Pulmonary Medicine, Rijnstate ziekenhuis, Arnhem, the Netherlands.
  • Verhagen AFTM; Department of Pulmonary Medicine, University of Groningen and University Medical Centre Groningen, Groningen, the Netherlands.
  • van Schil PE; Department of Pulmonary Medicine, VU University Medical Center, Amsterdam, the Netherlands.
  • Annema JT; Department of Surgery, VU University Medical Center, Amsterdam, the Netherlands.
  • van den Broek FJC; Department of Cardiothoracic Surgery, VU University Medical Center, Amsterdam, the Netherlands.
BMC Surg ; 18(1): 27, 2018 May 18.
Article en En | MEDLINE | ID: mdl-29776444
ABSTRACT

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 ).
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Endosonografía / Neoplasias Pulmonares / Mediastinoscopía Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Límite: Humans País como asunto: Europa Idioma: En Año: 2018 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Endosonografía / Neoplasias Pulmonares / Mediastinoscopía Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Límite: Humans País como asunto: Europa Idioma: En Año: 2018 Tipo del documento: Article