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ID
Source
Brief title
Health condition
Lungcancer and mediastinal staging
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- Cumulative length tissue core
- Suitability for molecular analysis/next-generation sequencing in patients with a final diagnosis of lung cancer
- Sample adequacy (defined as the presence of lymphocytes or atypical cells or other pathognomic characteristics (e.g. granulomas))
- Sample quality using the Mair’s objective scoring system
- Sample bloodiness
- Diagnostic sensitivity for mediastinal/hilar nodal staging (defined as the proportion of patients that have N2/N3 disease diagnosed by EBUS/EUS-B, relative to the total number of patients with a final diagnosis of N2/N3 disease as determined by the reference standard)
- Diagnostic sensitivity for malignancy (defined as the proportion of patients that have malignancy diagnosed by EBUS/EUS-B, relative to the total number of patients with a final diagnosis of malignancy as determined by the reference standard)
- Yield for diagnosing malignancy in the subgroup of patients with a centrally located lung tumor (defined as the proportion of patients that have malignancy diagnosed by EBUS/EUS-B, relative to the total number of patients with a final diagnosis of malignancy)
- Complication rate
- Procedure duration
- Endoscopists satisfaction of needle use
Background summary
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
Study objective
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
Study design
-
Intervention
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
Inclusion criteria
- (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
Exclusion criteria
- Mediastinal re-staging after neo-adjuvant treatment
- Contra-indication for EBUS or EUS/B
- Not correctable coagulation disorder
- Pregnancy
- Inability to consent
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7701 |
| Other | METC AMC : nl68824 |