Comparison of Diagnostic and Therapeutic Efficacy of EBUS-TBNA/EUS-FNA and TEMLA in Operable NSCLC.
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The aim of the study is prospective comparison of diagnostical and therapeutical efficiency
      between different methods of mediastinal lymph node preoperative staging in Non-Small-Cell
      Lung Cancer (NSCLC).

      Two hundred patients with histologically/cytologically confirmed clinical stage primary
      I-IIIA NSCLC will be included. The patients must be fit enough to undergo at least pulmonary
      lobectomy. Computer Tomography (CT) and Positron Emission Tomography (PET/CT) will be
      performed in all patients. Subsequently, the patients without evidence of dissemination will
      be randomized to transbronchial and transesophageal endoscopic ultrasound-guided needle
      aspiration ( EBUS-TBNA, EUS-NA) or Transcervical Extended Mediastinal Lymphadenectomy
      (TEMLA). The patients with N3 will be referred to definitive oncological treatment, the
      patients with N2 metastases will be referred to neoadjuvant treatment and the patients
      without N2/3 metastases will be operated on. The operative procedure will include at least
      lobectomy with complete lymphadenectomy, with open or video-assisted (VATS) technique. The
      patients undergoing sublobar resection will be excluded from this study. Final analysis will
      include comparison of the diagnostic yield and 5-year survival between the EBUS/EUS and the
      TEMLA arms.
    

Detailed description: 
      Non-Small-Cell Lung Cancer (NSCLC) is the most common malicious neoplasm characterized by
      very bad prognosis: 5-year survival rate is only 15%, and the main factors responsible for
      unfavorable treatment results are late diagnosis, rapid progression of the tumor and high
      rate of metastasis. The most important issue before selection of the treatment is to
      establish presence of the metastasis to nodes on the same side of the body (N2) and to lymph
      nodes on the other side of the mediastinum or a spread to the supraclavicular nodes (N3).

      A presence of metastasis to N2 (stage IIIA) is not an absolute contradiction for the surgical
      treatment but a discovery of N2 is followed by referral of the patients for neoadjuvant or
      adjuvant treatment depending if N2 are found before or after surgery. Presence of N3 is a
      contraindication for surgery and an indication for chemo-radiotherapy.

      Preoperative techniques of lymph nodes staging includes CT, PET/CT and endoscopy/ultrasound
      techniques EBUS-TBNA and EUS-NA. Surgical staging techniques include mediastinoscopy,
      anterior mediastinotomy, VATS, Video-mediastinoscopic lymphadenectomy (VAMLA) and TEMLA.

      Endobronchial Ultrasound guided Transbronchial Needle Aspiration (EBUS-TBNA) and Endoscopic
      Ultrasound guided Needle Aspiration (EUS-NA) are real-time imagining and biopsy techniques
      used in lung cancer staging. Transbronchial ultrasound examination allow to access upper and
      lower right paratracheal nodes (2R, 4R), subcarinal (7), hilar and interlobar (10, 11),
      transesophageal ultrasound examination allow to visualize upper and lower left paratracheal
      nodes (2L, 4L), subaortic (5), para-aortic (6), subcarinal (7), paraesophageal (8), pulmonary
      ligament (9) nodes. Furthermore EUS allow to localize mediastinal structures including heart,
      big vessels, main bronchi, vertebral column and diaphragm and can be used in for
      visualization of tumor infiltration of surrounding structures especially aorta, pulmonary
      artery or left atrium.

      Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is minimally invasive surgical
      technique enabling extensive bilateral lymphadenectomy. The procedure starts from 5-8 cm
      collar incision in the neck, sternum is elevated with a hook connected to a Rochard frame,
      both laryngeal recurrent nerves and vagus nerves are visualized. During TEMLA all mediastinal
      nodal stations except for the pulmonary ligament nodes (9) are removed.

      There are many controversions what is the optimal preoperative staging in patients with
      NSCLC.

      It this prospective randomized study we plan to compare preoperative staging with EBUS/EUS
      with TEMLA in 200 patients.

      The patients with histologically or cytologically proven clinical stage I-IIIA NSCLC will be
      included.

      The other inclusion criteria are no previous cancer treatment history, no medical
      contraindication to operation with at least pulmonary lobectomy, adequate cardiac and
      pulmonary function.

      All patients will undergo CT and PET/CT. The patients without dissemination of cancer will be
      randomized into the EBUS/EUS and the TEMLA arms. All patients with mediastinal metastasis
      discovered during staging will be referred to oncological treatment. Patients without
      mediastinal involvement will be treated with radical surgical treatment (lobectomy or
      pneumonectomy with lymphadenectomy) with open or video-assisted (VATS) technique. The
      patients undergoing sublobar resection will be excluded from this study.

      Final analysis will include comparison of the diagnostic yield and 5-year survival between
      the EBUS/EUS and the TEMLA arms. The study is intended to clarify the issue of the optimal
      preoperative staging and the possible impact of extended bilateral mediastinal
      lymphadenectomy on the survival of NSCLC.
    

Intervention name(s): PET/CT; EBUS-TBNA, EUS-NA; TEMLA
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): Positron Emission Tomography (PET/CT); Transbronchial and Transesophageal endoscopic ultrasound-guided needle aspiration ( EBUS-TBNA, EUS-NA) Transbronchial ultrasound examination allow to access upper and lower right paratracheal nodes (2R, 4R), subcarinal (7), hilar and interlobar (10, 11), transesophageal ultrasound examination allow to visualize upper and lower left paratracheal nodes (2L, 4L), subaortic (5), para-aortic (6), subcarinal (7), paraesophageal (8), pulmonary ligament (9) nodes. Furthermore EUS allow to localize mediastinal structures including heart, big vessels, main bronchi, vertebral column and diaphragm and can be used in for visualization of tumor infiltration of surrounding structures especially aorta, pulmonary artery or left atrium.; Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is minimally invasive surgical technique enabling extensive bilateral lymphadenectomy. The procedure starts from 5-8 cm collar incision in the neck, sternum is elevated with a hook connected to a Rochard frame, both laryngeal recurrent nerves and vagus nerves are visualized. During TEMLA all mediastinal nodal stations except for the pulmonary ligament nodes (9) are removed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment