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

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 - EBUS Acquire** Needle trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52438

Enrollment

Registered

2019-10-14

Start date

2019-10-30

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Lungcancer staging mediastinum

Interventions

Endosonography will be performed under sedation following the institutional practices

commonly either propofol or low dose midazolam/fentanyl sedation will be used. All patients will undergo a systematic endosonographic evaluation of all accessible mediastinal/hilar nodes. Following

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Measure

Time frame

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

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Secondary

Measure	Time frame
1. Cumulative length tissue core 2. Suitability for molecular analysis/next generation sequencing of 22 G TBNB vs 22 G TBNA needles 3. Sample adequacy(defined as the presence of lymphocytes or atypical cells or other pathognomic characteristics (e.g. granulomas)) 4. Sample quality using Mair*s objective scoring system 5. Sample bloodiness 6. 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) 7. 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) 8. 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) 9. Complication rate 10. Procedure duration 11. Endoscopist satisfaction of needle use	—

Measure

Time frame

1. Cumulative length tissue core 2. Suitability for molecular analysis/next generation sequencing of 22 G TBNB vs 22 G TBNA needles 3. Sample adequacy(defined as the presence of lymphocytes or atypical cells or other pathognomic characteristics (e.g. granulomas)) 4. Sample quality using Mair*s objective scoring system 5. Sample bloodiness 6. 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) 7. 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) 8. 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) 9. Complication rate 10. Procedure duration 11. Endoscopist satisfaction of needle use

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)