Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists
Completed
- Conditions
- Intrathoracic Lymphadenopathy
- Registration Number
- NCT03232684
- Lead Sponsor
- Maggiore Bellaria Hospital, Bologna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Maggiore Hospital
🇮🇹Bologna, Emilia Romagna, Italy
Maggiore Hospital🇮🇹Bologna, Emilia Romagna, Italy