Mediastinal LymphadenopathyPhase 4NCT01658280
Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies
A Phase 4 study testing EBUS-TBNA in people with Mediastinal Lymphadenopathy and Hilar Lymphadenopathy, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.
Trial summary
The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma
- What is being tested?
- EBUS-TBNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Jul 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18years;
- presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
- ability to give an informed consent.
Who cannot join
- presence of mediastinal adenopathy in stations 2R and 2L;
- coagulopathy or bleeding diathesis that cannot be corrected;
- severe refractory hypoxemia;
- unstable hemodynamic status;
- inability to give an informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'
Ancona, The Marches, 60100
About this study
Official title: Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration, Using Rapid On-site Cytological Evaluation, for the Diagnosis of Hilar/Mediastinal Enlarged Lymph Nodes: a Randomized Controlled Trial.
The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.
Read the detailed description
The role of transbronchial needle aspiration (TBNA) for the diagnosis of hilar/mediastinal adenopathy and lung cancer staging is well established. However, it is a blind procedure and its diagnostic yield seems to be related to the operator experience, as well as to the size and location of lymph nodes. In the recent years, there has been increased interest in imaging-assisted TBNA and the endobronchial ultrasound has been suggested to be feasible and to improve the diagnostic yield.
Another technique able to optimize the performance of transbronchial aspirations is the rapid on-site cytological examination (ROSE), allowing to assess the adequacy of samples collected. In this context, no comparative studies between standard TBNA and EBUS-TBNA have been performed. It is very important for clinical practice to definitively assess the possible superiority of EBUS-TBNA in terms of sensitivity, and to provide information regarding safety, procedural time and costs to define the best diagnostic strategy.
The study is focused on 252 patients who have at least one hilar/mediastinal lymph node > 1 cm on CT scan in at least one approachable lymph nodal station (except 2R and 2L) for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1 (control : intervention) by a computer-generated random-allocation system to undergo EBUS-TBNA or conventional TBNA. In case of failure of conventional TBNA, the operator will shift to EBUS procedure. Moreover,a subgroup analysis will be perform to assess the potential impact of lymphnode size and position on final results(univariate analysis).
- Being tested
- EBUS-TBNA
- Keywords
- transbronchial needle aspiration, ultrasound guided transbronchial needle aspiration, sensitivity, hilar/mediastinal adenopathy
- Medical subject headings
- Lymphoma, Lung Neoplasms, Sarcoidosis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNADevice
Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
| Study group | Role | What they receive |
|---|---|---|
| Conventional TBNA + ROSE | Active comparator | Patients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.
In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs Receives: Device: EBUS-TBNA |
| EBUS-TBNA + ROSE | Experimental | Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs Receives: Device: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
The sensitivity is defined as the rate of true positive diagnoses/(true positive + false negative). Sensitivity of EBUS-TBNA will be considered superior to that of conventional TBNA if it will achieve at least a value of 90%
Measured: 36 months
Secondary outcomes (5)
Specificity of TBNA and EBUS-TBNA
Specificity is defined as the rate of true negatives diagnoses /true negative + false positive
Measured: 36 months
Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
Measured: 36 months
Number of partecipants with adverse events
Measured: 36 months
Costs related to each diagnostic strategy
It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA.
Measured: 36 months
Procedural time
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mediastinal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Gasparini, Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Investigators
- Stefano Gasparini, Professor, Principal investigator, Azienda Ospedaliero, Universitaria Ospedali Riuniti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658280
- Sponsor's protocol ID
- PAN-001
- Status last verified
- Feb 2016
- First submitted
- 1 Aug 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Herth F, Becker HD, Ernst A. Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Chest. 2004 Jan;125(1):322-5. doi: 10.1378/chest.125.1.322.
PubMed 14718460Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. doi: 10.1159/000084041. No abstract available.
PubMed 15824520Toloza EM, Harpole L, Detterbeck F, McCrory DC. Invasive staging of non-small cell lung cancer: a review of the current evidence. Chest. 2003 Jan;123(1 Suppl):157S-166S. doi: 10.1378/chest.123.1_suppl.157s.
PubMed 12527575
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration, Using Rapid On-site Cytological Evaluation, for the Diagnosis of Hilar/Mediastinal Enlarged Lymph Nodes: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01658280
- Acronym / sponsor ID
- PAN-001
- Keywords
- transbronchial needle aspiration, ultrasound guided transbronchial needle aspiration, sensitivity, hilar/mediastinal adenopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali RiunitiUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Aug 2012 (estimated)
- 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 main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.
Detailed description
The role of transbronchial needle aspiration (TBNA) for the diagnosis of hilar/mediastinal adenopathy and lung cancer staging is well established. However, it is a blind procedure and its diagnostic yield seems to be related to the operator experience, as well as to the size and location of lymph nodes. In the recent years, there has been increased interest in imaging-assisted TBNA and the endobronchial ultrasound has been suggested to be feasible and to improve the diagnostic yield.
Another technique able to optimize the performance of transbronchial aspirations is the rapid on-site cytological examination (ROSE), allowing to assess the adequacy of samples collected. In this context, no comparative studies between standard TBNA and EBUS-TBNA have been performed. It is very important for clinical practice to definitively assess the possible superiority of EBUS-TBNA in terms of sensitivity, and to provide information regarding safety, procedural time and costs to define the best diagnostic strategy.
The study is focused on 252 patients who have at least one hilar/mediastinal lymph node > 1 cm on CT scan in at least one approachable lymph nodal station (except 2R and 2L) for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1 (control : intervention) by a computer-generated random-allocation system to undergo EBUS-TBNA or conventional TBNA. In case of failure of conventional TBNA, the operator will shift to EBUS procedure. Moreover,a subgroup analysis will be perform to assess the potential impact of lymphnode size and position on final results(univariate analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional TBNA + ROSE | Active comparator | Device: EBUS-TBNAPatients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist. In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs |
| EBUS-TBNA + ROSE | Experimental | Device: EBUS-TBNAPatients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18years;
- presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
- ability to give an informed consent.
Key exclusion criteria (5 listed)
- presence of mediastinal adenopathy in stations 2R and 2L;
- coagulopathy or bleeding diathesis that cannot be corrected;
- severe refractory hypoxemia;
- unstable hemodynamic status;
- inability to give an informed consent.
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 |
|---|---|---|
| EBUS-TBNAPatients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs | Device | Conventional TBNA + ROSE, EBUS-TBNA + ROSE |
Primary outcome
To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
Time frame: 36 months
The sensitivity is defined as the rate of true positive diagnoses/(true positive + false negative). Sensitivity of EBUS-TBNA will be considered superior to that of conventional TBNA if it will achieve at least a value of 90%
5 secondary outcomes
Specificity of TBNA and EBUS-TBNA
Time frame: 36 months
Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
Time frame: 36 months
Number of partecipants with adverse events
Time frame: 36 months
Costs related to each diagnostic strategy
Time frame: 36 months
Procedural time
Time frame: 36 months
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 3 Feb 2016.
- Background: PubMed 14718460Herth F, Becker HD, Ernst A. Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Chest. 2004 Jan;125(1):322-5. doi: 10.1378/chest.125.1.322.
- Background: PubMed 15824520Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. doi: 10.1159/000084041. No abstract available.
- Background: PubMed 12527575Toloza EM, Harpole L, Detterbeck F, McCrory DC. Invasive staging of non-small cell lung cancer: a review of the current evidence. Chest. 2003 Jan;123(1 Suppl):157S-166S. doi: 10.1378/chest.123.1_suppl.157s.
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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.
Stefano Gasparini, Professor principal investigator
Azienda Ospedaliero, Universitaria Ospedali Riuniti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EBUS-TBNA in people with Mediastinal Lymphadenopathy and Hilar Lymphadenopathy, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti 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 3 inclusion and 5 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 3 Feb 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies (time frame: 36 months). 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 NCT01658280, which also lists 3 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 3 Feb 2016.