Intrathoracic LymphadenopathyNCT03232684
Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists
An observational study of Intrathoracic Lymphadenopathy, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrathoracic Lymphadenopathy
- What is being tested?
- Rapid on-site evaluation
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with enlarged intratoracic lymph nodes
Who may be able to join
- Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?
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
- Being tested
- Rapid on-site evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid on-site evaluationDiagnostic test
On-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intrathoracic LymphadenopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Trisolini, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Rocco Trisolini, MD, Principal investigator, Policlinico S. Orsola & Maggiore Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232684
- Sponsor's protocol ID
- CE 17021
- Status last verified
- Aug 2018
- First submitted
- 21 Jul 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21030491Bonifazi 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.
PubMed 23846345
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?
- ClinicalTrials.gov ID
- NCT03232684
- Acronym / sponsor ID
- CE 17021
- Conditions
- Intrathoracic Lymphadenopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with enlarged intratoracic lymph nodes
Key inclusion criteria (2 listed)
- Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings
- Signed informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid on-site evaluationOn-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Background: PubMed 21030491Trisolini 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.
- Results publication: PubMed 23846345Bonifazi 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.
- Individual participant dataSharing planned: No
Related trials for Intrathoracic Lymphadenopathy
Recruiting
A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
Lung Lesions, Mediastinal and Hilar Lymph Node Enlargement
Not yet recruiting
Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy
Intrathoracic Lymphadenopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Trisolini, MD principal investigator
Policlinico S. Orsola & Maggiore Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrathoracic Lymphadenopathy, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples (time frame: Up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.