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

NCT03232684 | Completed

• 1 other identifier: CE 17021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrathoracic Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• 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 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

  Up to 1 week

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with enlarged intratoracic lymph nodes

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna: lead

Study Sites (1)

Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Location

Related Publications (2)

• 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.

  PMID: 21030491 BACKGROUND

• 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: 10.1378/chest.13-0756.

  PMID: 23846345 RESULT

Study Officials

• Rocco Trisolini, MD

  Policlinico S. Orsola & Maggiore Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Pulmonology Unit

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 28, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: June 30, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)