Clinical trial · Observational
Evaluation of the Utility of Rapid On-site Cytology Performed by an Interventional Pulmonologist During EBUS-TBNA.
Evaluation of the Utility of Rapid On-site Cytology (ROSE) Performed by an Interventional Pulmonologist During EBUS-TBNA. A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a single-centre, prospective observational analysis conducted at the Alessandria Hospital, aimed to evaluating the role of Rapid On-Site Evaluation (ROSE) performed directly by the interventional pulmonologist during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures. EBUS-TBNA is a gold-standard minimally invasive technique for the diagnosis and staging of mediastinal diseases, particularly lung cancer, allowing the collection of cytological material from lymph nodes and lesions adjacent to the airways. ROSE involves the immediate cytological assessment of the collected sample, with the aim of verifying its adequacy and providing an initial diagnostic indication directly in the operating theatre. Traditionally, this assessment is entrusted to the cytopathologist; however, their presence is not always guaranteed in clinical practice, due to organisational and resource constraints. For this reason, in recent years there has been growing interest in the possibility that the interventional pulmonologist, if adequately trained, could perform this assessment independently. The aim of the study is therefore to assess the usefulness of ROSE performed by a pulmonologist during EBUS-TBNA, by comparing the results obtained with those of the cytopathologist. In particular, the study analyses the agreement between the two professionals in terms of the adequacy of the cytological sample and diagnostic accuracy. The main question the study aims to answer is whether the on-the-spot cytological assessment performed by the pulmonologist is sufficiently reliable and consistent with that of the cytopathologist to be used in clinical practice as a valid alternative, particularly in situations where the cytopathologist is not present in the procedure room. The hypothesis underlying the study is that the use of ROSE by the pulmonologist may help to improve the efficiency of the procedure, reducing the number of needle passes, the duration of the examination and overall costs, without compromising diagnostic quality. The expected results could therefore have significant organisational and clinical implications, promoting wider adoption of ROSE and optimising the diagnostic and therapeutic pathway for patients undergoing EBUS-TBNA.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mediastinal Lymphadenopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing transbronchial needle aspiration guided by EBUS (EBUS-TBNA)
- description
- Patients undergoing EBUS-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal and hilar lymph nodes or lesions adjacent to the airways
- interventionNames
- Other: data collection
Primary outcomes (1)
- measure
- Assessment of the usefulness of the ROSE procedure
- timeFrame
- From enrollment to end of procedures and analysis
- description
- This prospective observational study aims to assess the utility of ROSE performed by an interventional pulmonologist during EBUS-TBNA, by comparing the results obtained by the cytopathologist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult male or female subjects aged 18 years or over; * Patients who have undergone EBUS-TBNA for suspected cancer; * Signed informed consent. Exclusion Criteria: * High-risk conditions for performing bronchoscopy and/or EBUS-TBNA * Lack of a signed informed consent form.
References
Publications (0)
Data not yet available