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

NCT03188562 | Completed

• 1 other identifier: 02/2014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• comparison of the diagnostic yield of EBUS/EUS and TEMLA

  after radical surgical treatment (lobectomy or pneumonectomy with lymphadenectomy)

  2 weeks after the end of surgery

Secondary Outcomes (1)

• 5-year survival between the EBUS/EUS and the TEMLA arms

  5-year

Study Arms (2)

EBUS-TBNA, EUS-NA

EXPERIMENTAL

1. PET/CT 2. Transbronchial and Transesophageal endoscopic ultrasound-guided needle aspiration ( EBUS-TBNA, EUS-NA)

Other: PET/CT; Procedure: EBUS-TBNA, EUS-NA

TEMLA

EXPERIMENTAL

1. PET/CT 2. Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)

Other: PET/CT; Procedure: TEMLA

Interventions

PET/CT OTHER

Positron Emission Tomography (PET/CT)

EBUS-TBNA, EUS-NA; TEMLA

EBUS-TBNA, EUS-NA PROCEDURE

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.

EBUS-TBNA, EUS-NA

TEMLA PROCEDURE

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.

TEMLA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with histologically or cytologically proven clinical stage I-IIIA NSCLC
• no medical contraindication to operation with at least pulmonary lobectomy
• adequate cardiac and pulmonary function

You may not qualify if:

• previous cancer treatment history

Sponsors & Collaborators

• Pulmonary Hospital Zakopane: lead

Study Sites (1)

Pulmonary Hospital

Zakopane, 34-500, Poland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcin Zielinski, PhD

  Pulmonary Hospital, Zakopane, Poland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: May 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

PL (1)