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

NCT07590947 | Completed

• 1 other identifier: ASO.Pneumo.22.01
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EBUS-TBNA; Endobronchial Ultrasound; Transbronchial Needle Aspiration; Rapid On-Site Evaluation (ROSE); Cytodiagnosis; Lung Cancer; Mediastinal Lymph Nodes; Interventional Pulmonology

Outcome Measures

Primary Outcomes (1)

• Assessment of the usefulness of the ROSE procedure

  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.

  From enrollment to end of procedures and analysis

Study Arms (1)

Patients undergoing transbronchial needle aspiration guided by EBUS (EBUS-TBNA)

Patients undergoing EBUS-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal and hilar lymph nodes or lesions adjacent to the airways

Other: data collection

Interventions

data collection OTHER

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

Patients undergoing transbronchial needle aspiration guided by EBUS (EBUS-TBNA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise adult patients of both sexes referred to the Department of Respiratory Medicine at the "SS Antonio e Biagio e Cesare Arrigo" Hospital in Alessandria who are undergoing EBUS-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal and hilar lymph nodes or lesions adjacent to the airways

You may qualify if:

• Adult male or female subjects aged 18 years or over;
• Patients who have undergone EBUS-TBNA for suspected cancer;
• Signed informed consent.

You may not qualify if:

• High-risk conditions for performing bronchoscopy and/or EBUS-TBNA
• Lack of a signed informed consent form.

Sponsors & Collaborators

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

Study Sites (1)

SC Respiratory Diseases

Alessandria, 15121, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: May 22, 2022
• Primary Completion: July 18, 2024
• Study Completion: December 31, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-04

Locations

IT (1)