Endobronchial ultrasound in diagnosing and staging of Lung cancer22 G TBNB vs 22 G TBNA needles; a randomized controlled trial: EBUS Acquire?? Needle Trial

’Endobronchial ultrasound in diagnosing and staging of Lung cancer22 G TBNB vs 22 G TBNA needles; a randomized controlled trial: EBUS Acquire?? Needle Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20056

Enrollment

120

Registered

2019-04-15

Start date

2019-09-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lungcancer and mediastinal staging

Interventions

We will compare the novel Acquire?? needle 22 G TBNB vs 22 G TBNA standard Boston Scientific needles for the diagnosis and staging of lung cancer

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
1.The suitability rate for the assessment of PD-L1 expression with the EBUS / EUS-B 22 G TBNB novel Boston Acquire?? 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

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Contacts

Public ContactJolanda Kuijvenhoven

Amsterdam UMC, loc AMC

j.c.kuijvenhoven@amsterdamumc.nl0031205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)