Clinical trial · Interventional
Combined Application of EBUS and EUS in Lung Cancer
Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.
- 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)
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBUS-TBNA followed by EUS-B-FNA | Procedure | — | UNRESOLVED |
| EUS-B-FNA followed by EBUS-TBNA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- EBUS centered
- interventionNames
- Procedure: EUS-B-FNA followed by EBUS-TBNA
- type
- EXPERIMENTAL
- label
- Arm B
- description
- EUS centered
- interventionNames
- Procedure: EBUS-TBNA followed by EUS-B-FNA
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC) * Potentially operable patients Exclusion Criteria: * M1 disease * Inoperable T4 disease * Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT. * Confirmed supraclavicular lymph node metastasis * Pancoast tumors * Medically inoperable patients * Contraindications for bronchoscopy and esophageal endoscopy * Drug reaction to lidocaine, midazolam,fentanyl * Pregnancy * Ground glass-dominant nodule ( \< 3cm)
References
Publications (1)
- DERIVEDKang HJ, Hwangbo B, Lee GK, Nam BH, Lee HS, Kim MS, Lee JM, Zo JI, Lee HS, Han JY. EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial. Thorax. 2014 Mar;69(3):261-8. doi: 10.1136/thoraxjnl-2013-203881. Epub 2013 Oct 30. PMID 24172712