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OpenTrials
Completed

NCT Number: NCT03232684

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

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.

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Key information

Conditions

Intrathoracic Lymphadenopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid on-site evaluation

Diagnostic Test

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

Primary outcomes

  1. Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples

    Time frame: Up to 1 week

    The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard

Secondary outcomes

  1. 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 inflammation

    Time frame: Up to 1 week

    The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard

Sponsors and collaborators

Lead sponsor

Maggiore Bellaria Hospital, Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2017
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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