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NCT03188562

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

Completed NA Last updated 4 June 2019
What this trial tests

NA trial testing PET/CT in Non-small Cell Lung Cancer in 200 participants. Completed in 1 December 2017.

Timeline
1 May 2011
Primary endpoint
1 December 2017
1 December 2017

Quick facts

Lead sponsorPulmonary Hospital Zakopane
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date1 May 2011
Primary completion1 December 2017
Estimated completion1 December 2017
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Pulmonary Hospital Zakopane

Who can join

Adults 18 to 85, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of the Diagnostic Efficiency of Mediastinal Lymph Node Endobronchial and Endoesophageal Ultrasound with Transcervical Extended Mediastinal Lymphadenectomy in Operable Non-Small Cell Lung Cancer.
    Wilkojc M, Gwozdz P, Kosinski S, Pankowski J, et al · · 2025 · PMID 40647505 · DOI 10.3390/cancers17132207

Verify or expand the search:

Other trials of PET/CT

Trials testing the same drug.

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

Other Pulmonary Hospital Zakopane trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing