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Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists

Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03232684
Enrollment
200
Registered
2017-07-28
Start date
2017-06-01
Completion date
2018-06-30
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrathoracic Lymphadenopathy

Brief summary

The study is aimed at verifying if a pulmonologist in training can reliably assess the adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training provided by an experienced pathologist.

Interventions

On-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA

Sponsors

Maggiore Bellaria Hospital, Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings * Signed informed consent

Exclusion criteria

* High risk conditions for the performance of bronchoscopy and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) * High risk condition for deep sedation (ASA 4) * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samplesUp to 1 weekThe Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard

Secondary

MeasureTime frameDescription
Accuracy with which the pulmonologist will be able, in case of adequate EBUS-TBNA sample, to assign the specimen to one of the following specific diagnoses: 1) reactive lymph node; 2) malignancy; 3) granulomatous inflammationUp to 1 weekThe Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026