Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA

Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02813603

Enrollment

100

Registered

2016-06-27

Start date

2016-05-31

Completion date

2018-03-31

Last updated

2018-07-12

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

Conditions

Lung Cancer

Keywords

EBUS-TBNA, staging, lymph node metastases

Brief summary

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

Detailed description

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Interventions

PROCEDUREEBUS

19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients aged over 18 * Patients signed written informed consent * Mediastinal or hilar enlarged lymph nodes (\>10mm) in short axis radiological or clinical findings likely for lung cancer

Exclusion criteria

* Severe impairment of any organs, with do not enable anaesthesia * Quick \<80%, INR \>1,5, thrombocytes \<50/nl or PTT\>120sec * Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study. * Insufficient language ability (spoken and written German)

Design outcomes

Primary

Measure	Time frame
sample weight	February 2017

Secondary

Measure	Time frame
The number of complications like bleeding, infections, pneumothorax and pain	February 2017

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026