Distinguishing N2a from N2b lymph node spread during EBUS-TBNA and whether changing the needle helps
Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07418450 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Daniela Gompelmann
- Email: daniela.gompelmann@meduniwien.ac.at
- Phone: 0043 1 40400 47730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.