Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07418450

Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study

Led by University of Vienna · Updated on 2026-02-18

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether changing the needle between lymph node stations during EBUS-TBNA staging improves discrimination between N2a and N2b in patients with mediastinal lymphadenopathy suspected or confirmed to have lung cancer. This prospective pilot study aims to compare two rounds of EBUS staging to assess the necessity of needle changes during the procedure. The study involves performing an initial round of EBUS-TBNA staging where the needle is changed between all lymph node stations, followed by a second round without changing the needle. This comparison seeks to determine if needle change affects the agreement between staging results. Participants will undergo these two rounds of EBUS staging during the same procedure. Researchers will measure the agreement between the two rounds over 18 months to evaluate if changing the needle influences staging accuracy. The study involves adult patients who have a pulmonary lesion suspicious for or confirmed as lung cancer and require mediastinal staging.

CONDITIONS

Brief Title

Discrimination of N2a and N2b by EBUS-TBNA: is a Change of the Needle Necessary?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pulmonary lesion suspicious for lung cancer or histologically confirmed lung cancer
  • Indication for mediastinal staging
  • Age 18 years or older
Not Eligible

You will not qualify if you...

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single procedure visit

Participants undergo endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with and without needle change between lymph node stations to discriminate N2a and N2b.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria

Actively Recruiting

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Research Team

D

Daniela Gompelmann

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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