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

NCT ID: NCT03232684

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Intrathoracic Lymphadenopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role lead

Responsible Party

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Rocco Trisolini

Director, Interventional Pulmonology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocco Trisolini, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico S. Orsola & Maggiore Hospitals

Locations

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Maggiore Hospital

Bologna, Emilia-Romagna, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 21030491 (View on PubMed)

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.

Reference Type RESULT
PMID: 23846345 (View on PubMed)

Other Identifiers

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CE 17021

Identifier Type: -

Identifier Source: org_study_id

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