EBUS/EUS-B sampling of mediastinal/hilar lymph nodes and/or primary lung tumors with the Acquireᵗᵐ 22G TBNB needle has a higher suitability rate for the assessment of PD-L1 expression in comparison to the regular 22G TBNA needle in patients with…
ID
Bron
Verkorte titel
Aandoening
Lungcancer and mediastinal staging
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The suitability rate for the assessment of PD-L1 expression with the EBUS / EUS-B 22 G TBNB novel Boston Acquireᵗᵐ needle vs 22 G TBNA Boston Scientific BSC standard needle on mediastinal/hilar nodal or tumor aspirates in patients with a final diagnosis of lung cancer.
Achtergrond van het onderzoek
Patients with (suspected) lung cancer and an indication for mediastinal/hilar nodal or lung tumor sampling by EBUS-TBNA and /or EUS-B FNA according to current guidelines.
Indications for mediastinal staging are: suspicion of mediastinal or hilar lymph node metastases based either on size (short axis > 10mm on CT) or increased FDG uptake; centrally located primary tumor, FDG-negative tumor). Centrally located lung tumors adjacent to the major airways or esophagus can be sampled by EBUS/EUS-B.
In this randomised study we will compare the novel Acquireᵗᵐ needle 22 G TBNB vs 22 G TBNA standard Boston Scientific needles for the diagnosis and staging of lung cancer.
Hypothesis: EBUS/EUS-B sampling of mediastinal/hilar lymph nodes and/or primary lung tumors with the Acquireᵗᵐ 22G TBNB needle has a higher suitability rate for the assessment of PD-L1 expression in comparison to the regular 22G TBNA needle in patients with lung cancer
Doel van het onderzoek
EBUS/EUS-B sampling of mediastinal/hilar lymph nodes and/or primary lung tumors with the Acquireᵗᵐ 22G TBNB needle has a higher suitability rate for the assessment of PD-L1 expression in comparison to the regular 22G TBNA needle in patients with lung cancer
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
We will compare the novel Acquireᵗᵐ needle 22 G TBNB vs 22 G TBNA standard Boston Scientific needles for the diagnosis and staging of lung cancer
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- (suspected) NSCLC/SCLC
- Indication for mediastinal/hilar nodal or lung tumor tissue sampling
- Suspected mediastinal/hilar lymph nodes or lung tumor within reach of EBUS/ EUS-B
- 18 years or older
- Provision of a written consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Mediastinal re-staging after neo-adjuvant treatment
- Contra-indication for EBUS or EUS/B
- Not correctable coagulation disorder
- Pregnancy
- Inability to consent
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7701 |
| Ander register | METC AMC : nl68824 |