Interstitial Lung DiseaseNCT02201654
Stylet vs No Stylet During EBUS TBNA
A study testing EBUS without stylet in people with Interstitial Lung Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- EBUS without stylet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2015
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients >18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.
Who cannot join
- Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest.
The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.
- Conditions
- Interstitial Lung Disease
- Being tested
- EBUS without stylet
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS without styletOther
the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.
| Study group | Role | What they receive |
|---|---|---|
| EBUS patients | Other | All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis. Receives: Other: EBUS without stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement (percentage of samples that have the same diagnosis)
The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.
Measured: At time of biopsy
Secondary outcomes (3)
Pneumothorax rate (percentage of procedures that result in a pneumothorax)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Measured: 1 week post-procedure
Bleeding rate (% of procedures that have significant bleeding)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Measured: 1 week post-procedure
Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Measured: 1 week post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201654
- Sponsor's protocol ID
- NA_00093452
- Status last verified
- Dec 2016
- First submitted
- 5 Jun 2014
- Last updated
- 15 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)
- ClinicalTrials.gov ID
- NCT02201654
- Acronym / sponsor ID
- NA_00093452
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Jul 2014 (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.
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest.
The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS patients | Other | Other: EBUS without styletAll patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.
Key exclusion criteria (2 listed)
- Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
- Pregnant women
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 without styletthe patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis. | Other | EBUS patients |
Primary outcome
Diagnostic agreement (percentage of samples that have the same diagnosis)
Time frame: At time of biopsy
The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.
3 secondary outcomes
Pneumothorax rate (percentage of procedures that result in a pneumothorax)
Time frame: 1 week post-procedure
Bleeding rate (% of procedures that have significant bleeding)
Time frame: 1 week post-procedure
Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
Time frame: 1 week post-procedure
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 15 Dec 2016.
Related trials for Interstitial Lung Disease
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Registry for Patients With Erdheim-Chester Disease and Other Histiocytoses
Erdheim-Chester Disease
Recruiting
Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension
Pulmonary Hypertension, Interstitial Lung Disease (ILD)
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 without stylet in people with Interstitial Lung Disease, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 2 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 15 Dec 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 United States. 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?
Diagnostic agreement (percentage of samples that have the same diagnosis) (time frame: At time of biopsy). 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 15 Dec 2016.