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NCT03188562
Comparison of Diagnostic and Therapeutic Efficacy of EBUS-TBNA/EUS-FNA and TEMLA in Operable NSCLC.
NA trial testing PET/CT in Non-small Cell Lung Cancer in 200 participants. Completed in 1 December 2017.
1 December 2017
Quick facts
| Lead sponsor | Pulmonary Hospital Zakopane |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 May 2011 |
| Primary completion | 1 December 2017 |
| Estimated completion | 1 December 2017 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- PET/CT
- EBUS-TBNA, EUS-NA
- TEMLA
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
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):
-
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:
- PubMed search for NCT03188562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pulmonary Hospital Zakopane trials
Trials by the same sponsor.
- NCT03997799 — Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer · NA · unknown
- NCT03228056 — Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03188562 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pulmonary Hospital Zakopane
- Last refreshed: 4 June 2019
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