Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
Completed
- Conditions
- Lung Cancer
- Interventions
- Procedure: EBUS
- Registration Number
- NCT02813603
- Lead Sponsor
- University Hospital, Essen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Intervention (22-gauge) EBUS After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle Study Product (19-gauge) EBUS After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
- Primary Outcome Measures
Name Time Method sample weight February 2017
- Secondary Outcome Measures
Name Time Method The number of complications like bleeding, infections, pneumothorax and pain February 2017
Trial Locations
- Locations (2)
University Hospital Zürich
🇨🇭Zürich, Switzerland
Ruhrlandklinik, University Hospital Essen
🇩🇪Essen, NRW, Germany