Distinguishing N2a from N2b lymph node spread during EBUS-TBNA and whether changing the needle helps
Official title: Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study
Run by University of Vienna · NCT07418450 · Data updated 2026-11-12
It will see if changing the EBUS-TBNA needle between lymph nodes helps doctors tell apart N2a from N2b in people having mediastinal staging for suspected or confirmed lung cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07418450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a pulmonary lesion suspicious for or already diagnosed as lung cancer who are scheduled for EBUS-TBNA mediastinal staging and can undergo bronchoscopy at the participating center.
✕Probably not a fit
Patients not undergoing EBUS-TBNA mediastinal staging, those who cannot safely undergo bronchoscopy, or those whose nodal status is already established by other means are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergoing EBUS-TBNA for mediastinal staging will have two sequential rounds of sampling: one round with a new needle for each sampled lymph node and a second round using the same needle across nodes. Collected cytology and pathology will be compared to determine whether needle change affects the ability to distinguish single‑station (N2a) from multi‑station (N2b) mediastinal nodal involvement. The trial enrolls patients with a pulmonary lesion suspicious for or already diagnosed as lung cancer who have an indication for mediastinal staging. Outcomes likely include diagnostic classification and measures of sample quality and potential cross‑contamination.
Why it matters
Potential benefit: If successful, the results could simplify and speed up mediastinal staging by showing whether needle changes are necessary, potentially reducing procedure time, needle use and cost without lowering diagnostic accuracy.
How similar studies have gone: Direct evidence comparing needle change versus no change for discriminating N2a versus N2b is limited, making this a relatively novel procedural question though related work on needle passes and contamination is sparse and inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pulmonary lesion suspicious for lung cancer or histologically confirmed lung cancer * indication for mediastinal staging Exclusion Criteria: \-
Where it's running
-
Medical University of Vienna
Vienna, Austria Recruiting
Study contacts
- Study coordinator: Daniela Gompelmann
- Email: daniela.gompelmann@meduniwien.ac.at
- Phone: 0043 1 40400 47730
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.