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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
Sponsor:
Collaborator:
University Hospital, Zürich
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen

Study Description
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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.

Condition or disease Intervention/treatment
Lung Cancer Procedure: EBUS

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.
Study Design
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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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Study Product (19-gauge)
After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
 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
 Procedure: EBUS
19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.


Outcome Measures
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Primary Outcome Measures :
  1. sample weight [ Time Frame: February 2017 ]

Secondary Outcome Measures :
  1. The number of complications like bleeding, infections, pneumothorax and pain [ Time Frame: February 2017 ]

Eligibility Criteria
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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
Study Population
100 Patients with lung cancer and enlarged lymph nodes will be included in this study
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Ruhrlandklinik, University Hospital Essen
Essen, NRW, Germany, 45147
Switzerland
University Hospital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University Hospital, Essen
University Hospital, Zürich
Investigators
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Study Director: Kaid Darwiche, PD Dr. med. supervising doctor
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Kaid Darwiche, University Hospital, Essen:
EBUS-TBNA
staging
lymph node metastases