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

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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

sample weight [ Time Frame: February 2017 ]

Secondary Outcome Measures :

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.

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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

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