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

NCT ID: NCT02813603

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

EBUS

Intervention Type PROCEDURE

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

EBUS

Intervention Type PROCEDURE

19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.

Interventions

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EBUS

19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Kaid Darwiche

Priv. Doz. Dr. med. Kaid Darwiche

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaid Darwiche, PD Dr. med.

Role: STUDY_DIRECTOR

supervising doctor

Locations

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Ruhrlandklinik, University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

University Hospital Zürich

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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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.

Reference Type DERIVED
PMID: 30914312 (View on PubMed)

Other Identifiers

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EBUS19VS22

Identifier Type: -

Identifier Source: org_study_id

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