Mediastinal Lymph Node EnlargementNCT01836822
Bronchoscopic Sampling Techniques in Sarcoidosis
A study testing EBUS guided transbronchial forceps biopsy (EBUS-TBFB), EBUS guided transbronchial needle aspiration (EBUS-TBNA) and large bore (19G) histologic needle biopsy of the mediastinal lymph nodes in people with Mediastinal Lymph Node Enlargement and Sarcoidosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mediastinal Lymph Node Enlargement, Sarcoidosis, Tuberculosis
- What is being tested?
- EBUS guided transbronchial forceps biopsy (EBUS-TBFB), EBUS guided transbronchial needle aspiration (EBUS-TBNA) and large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2013to May 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provided informed consent
- mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling
- clinical presentation that might be consistent with sarcoidosis
Who cannot join
- age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
- lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement
Trial locations and contacts
1 site in 1 country.
Rafal Krenke, MD, PhD contact
Piotr Korczynski, MD, PhD contact
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, 02-097
Rafal Krenke, MD, PhD, +48225992562, rafalkrenke@interia.pl
Piotr Korczynski, MD, PhD, +48225992562, drkorczynski@gmail.com
About this study
Official title: Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.
Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.
Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.
- Being tested
- EBUS guided transbronchial forceps biopsy (EBUS-TBFB), EBUS guided transbronchial needle aspiration (EBUS-TBNA), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, Bronchoalveolar lavage (BAL), Endobronchial forceps biopsy
- Keywords
- mediastinal lymph node enlargement, sarcoidosis, bronchoscopy, EBUS guided transbronchial needle aspiration (EBUS-TBNA), transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy EBUS-TBFB)
- Medical subject headings
- Sarcoidosis, Tuberculosis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS guided transbronchial forceps biopsy (EBUS-TBFB)Procedure or surgery
Also called EBUS guided miniforceps biopsy
EBUS guided transbronchial needle aspiration (EBUS-TBNA)Procedure or surgery
large bore (19G) histologic needle biopsy of the mediastinal lymph nodesProcedure or surgery
Bronchoalveolar lavage (BAL)Procedure or surgery
Endobronchial forceps biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopic lymph node sampling | Experimental | Several different sampling techniques will be used in each patient. They include: EBUS guided transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, forceps biopsy of bronchial mucosa in central and peripheral bronchi Receives: Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB); Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA); Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes; Procedure: Bronchoalveolar lavage (BAL); Procedure: Endobronchial forceps biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.
Measured: Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Secondary outcomes (1)
Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.
Comparison of the number of patients in whom the specific sampling method has been undertaken (e.g. BAL, EBUS-TBNA, EBUS-TBFB and large bore TBNA) with the number of patients in whom the specific sampling method provided the adequate specimens, containing the elements of granulomas (also the relationship between the mediastinal lymph node dimension and the quality of the samples collected with different techniques)
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal Lymph Node EnlargementStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Krenke, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836822
- Sponsor's protocol ID
- IPU-DIMPA-WUM13(1)
- Status last verified
- Feb 2014
- First submitted
- 17 Apr 2013
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
- ClinicalTrials.gov ID
- NCT01836822
- Acronym / sponsor ID
- IPU-DIMPA-WUM13(1)
- Keywords
- mediastinal lymph node enlargement, sarcoidosis, bronchoscopy, EBUS guided transbronchial needle aspiration (EBUS-TBNA), transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy EBUS-TBFB)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 22 Apr 2013 (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 development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.
Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.
Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopic lymph node sampling | Experimental | Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB), Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA), Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, Procedure: Bronchoalveolar lavage (BAL), Procedure: Endobronchial forceps biopsySeveral different sampling techniques will be used in each patient. They include: EBUS guided transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, forceps biopsy of bronchial mucosa in central and peripheral bronchi |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provided informed consent
- mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling
- clinical presentation that might be consistent with sarcoidosis
Key exclusion criteria (3 listed)
- age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
- lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement
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 guided transbronchial forceps biopsy (EBUS-TBFB)Also: EBUS guided miniforceps biopsy | Procedure or surgery | Bronchoscopic lymph node sampling |
| EBUS guided transbronchial needle aspiration (EBUS-TBNA) | Procedure or surgery | Bronchoscopic lymph node sampling |
| large bore (19G) histologic needle biopsy of the mediastinal lymph nodes | Procedure or surgery | Bronchoscopic lymph node sampling |
| Bronchoalveolar lavage (BAL) | Procedure or surgery | Bronchoscopic lymph node sampling |
| Endobronchial forceps biopsy | Procedure or surgery | Bronchoscopic lymph node sampling |
Primary outcome
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Time frame: Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.
1 secondary outcome
Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.
Time frame: up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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.
Rafal Krenke, MD, PhD contact
Piotr Korczynski, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS guided transbronchial forceps biopsy (EBUS-TBFB), EBUS guided transbronchial needle aspiration (EBUS-TBNA) and large bore (19G) histologic needle biopsy of the mediastinal lymph nodes in people with Mediastinal Lymph Node Enlargement and Sarcoidosis, run by Medical University of Warsaw at 1 site in Poland.
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 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: status not confirmed, as of the sponsor's last update on 12 Feb 2014. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafal Krenke, MD, PhD (rafalkrenke@interia.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis. (time frame: Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2014.