Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
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ClinicalTrials.gov Identifier: NCT02813603 |
Recruitment Status :
Completed
First Posted : June 27, 2016
Last Update Posted : July 12, 2018
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Condition or disease | Intervention/treatment |
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Lung Cancer | Procedure: EBUS |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | March 2018 |

Group/Cohort | Intervention/treatment |
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Study Product (19-gauge)
After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
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Procedure: EBUS
19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes. |
Control Intervention (22-gauge)
After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
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Procedure: EBUS
19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes. |
- sample weight [ Time Frame: February 2017 ]
- The number of complications like bleeding, infections, pneumothorax and pain [ Time Frame: February 2017 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813603
Germany | |
Ruhrlandklinik, University Hospital Essen | |
Essen, NRW, Germany, 45147 | |
Switzerland | |
University Hospital Zürich | |
Zürich, Switzerland |
Study Director: | Kaid Darwiche, PD Dr. med. | supervising doctor |
Responsible Party: | Kaid Darwiche, Priv. Doz. Dr. med. Kaid Darwiche, University Hospital, Essen |
ClinicalTrials.gov Identifier: | NCT02813603 |
Other Study ID Numbers: |
EBUS19VS22 |
First Posted: | June 27, 2016 Key Record Dates |
Last Update Posted: | July 12, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
EBUS-TBNA staging lymph node metastases |