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

Recruiting

• Conditions: Lungcancer; staging mediastinum; 10029107

• Registration Number: NL-OMON52438
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients with (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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>1. The suitability rate for the assessment of PD-L1 expression on the cell<br /><br>block preparation with the EBUS/EUS-B 22 G TBNB Boston Acquire** needle vs 22 G<br /><br>TBNA Boston Scientific standard needle of mediastinal/hilar nodal or tumor<br /><br>aspirates in patients with a final diagnosis of lung cancer. Cell block<br /><br>specimens will be considered suitable if more than 100 tumor cells are present<br /><br>in the specimen. </p><br>