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Evaluation of the Utility of Rapid On-site Cytology Performed by an Interventional Pulmonologist During EBUS-TBNA.

NCT07590947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 189

Last updated 2026-05-15

No results posted yet for this study

Summary

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

  • Mediastinal Lymphadenopathy
  • Lung Neoplasms

Interventions

OTHER

data collection

patients undergoing EBUS-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal and hilar lymph nodes or lesions adjacent to the airways. Data are collected in a dedicated electronic database

Sponsors & Collaborators

  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-22
Primary Completion
2024-07-18
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07590947 on ClinicalTrials.gov