Comparison of Diagnostic and Therapeutic Efficacy of EBUS-TBNA/EUS-FNA and TEMLA in Operable NSCLC.

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

OTHER

PET/CT

Positron Emission Tomography (PET/CT)

PROCEDURE

EBUS-TBNA, EUS-NA

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.

PROCEDURE

TEMLA

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.

Sponsors & Collaborators

• Pulmonary Hospital Zakopane

  lead OTHER

Principal Investigators

• Marcin Zielinski, PhD · Pulmonary Hospital, Zakopane, Poland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-01

Primary Completion

2017-12-01

Completion

2017-12-01

Countries

• Poland

Study Locations