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

July 10, 2018 updated by: Kaid Darwiche, University Hospital, Essen

Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45147
        • Ruhrlandklinik, University Hospital Essen
  • Switzerland
      • Zürich, Switzerland
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 Patients with lung cancer and enlarged lymph nodes will be included in this study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sample weight
Time Frame: February 2017
February 2017

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of complications like bleeding, infections, pneumothorax and pain
Time Frame: February 2017
February 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Collaborators

University Hospital, Zürich

Investigators

  • Study Director: Kaid Darwiche, PD Dr. med., supervising doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EBUS19VS22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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