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

Intrathoracic Lymphadenopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232684
• Other study ID #: CE 17021
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2018
• Source: Maggiore Bellaria Hospital, Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2018
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrathoracic Lymphadenopathy
• Lymphadenopathy

Intervention

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

Locations

Country	Name	City	State
Italy	Maggiore Hospital	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bonifazi M, Sediari M, Ferretti M, Poidomani G, Tramacere I, Mei F, Zuccatosta L, Gasparini S. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014 Jan;145(1):60-65. doi: — View Citation

Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples	The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard	Up to 1 week
Secondary	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	The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard	Up to 1 week