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

U

University Hospital Essen

Status

Completed

Conditions

Lung Cancer

Treatments

Procedure: EBUS

Study type

Observational

Funder types

Other

Identifiers

NCT02813603
EBUS19VS22

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

100 participants in 2 patient groups

Study Product (19-gauge)
Description:
After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
Treatment:
Procedure: EBUS
Control Intervention (22-gauge)
Description:
After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
Treatment:
Procedure: EBUS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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