Clinical trial · Interventional
Comparison of Diagnostic and Therapeutic Efficacy of EBUS-TBNA/EUS-FNA and TEMLA in Operable NSCLC.
Comparison of Diagnostic and Therapeutic Efficacy of Endobronchial/Endoesophageal Ultrasound and Transcervical Extended Mediastinal Lymphadenectomy in Non-Small-Cell Lung Cancer. A Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBUS-TBNA, EUS-NA | Procedure | — | UNRESOLVED |
| PET/CT | Other | — | UNRESOLVED |
| TEMLA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EBUS-TBNA, EUS-NA
- description
- 1. PET/CT 2. Transbronchial and Transesophageal endoscopic ultrasound-guided needle aspiration ( EBUS-TBNA, EUS-NA)
- interventionNames
- Other: PET/CT
- Procedure: EBUS-TBNA, EUS-NA
- type
- EXPERIMENTAL
- label
- TEMLA
- description
- 1. PET/CT 2. Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)
- interventionNames
- Other: PET/CT
- Procedure: TEMLA
Primary outcomes (1)
- measure
- comparison of the diagnostic yield of EBUS/EUS and TEMLA
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * previous cancer treatment history
References
Publications (0)
Data not yet available