SarcoidosisPhase 2/3NCT02875756
Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
A Phase 2/3 study testing 10 revolutions and 20 revolutions in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- 10 revolutions and 20 revolutions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2016to Dec 2017
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group of 18 to 65 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
Who cannot join
- Hypoxemia (SpO2 <92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
- Failure to provide informed consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012
About this study
Official title: A Study Evaluating the Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
The investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis.
Read the detailed description
Sarcoidosis is a multisystem disorder of unknown etiology characterized by granulomatous inflammation involving various body organs. The diagnosis is made on the basis of compatible clinicoradiological feature, histopathologic evidence of non-caseating granuloma, and exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling.
Among the bronchoscopic techniques, TBNA of lymph nodes has emerged as the most useful modality in addition to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA are well established. With improvements in technology, last decade has seen the use of EBUS to guide transbronchial needle aspiration. This technique is a minimally invasive and offers the additional advantage of choosing the appropriate node for sampling based on the vascularity, echogenicity and size. Studies subsequently have demonstrated the superiority EBUS-TBNA over conventional TBNA.
Once the role of TBNA in diagnostic bronchoscopy was clear, technical aspects of the procedure became the topic of research. This includes the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the distance travelled by the needle within the lymph node. The number of revolutions i.e. the number of times the needle should be moved back-and-forth inside the lymph node is one such factor. The recommendation is to move the needle ten to twenty times. However the optimum number of times the needle should be moved back and forth for extracting adequate tissue material has not been studied to date. The investigators have observed that performing revolutions during EBUS-TBNA frequently leads to aspiration of blood during the procedure.
The investigators hypothesize that the number of revolutions will not affect the diagnostic yield, and the yield would be similar in 10 compared to 20 revolutions. In this study, the investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of EBUS-TBNA in patients with sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- 10 revolutions, 20 revolutions
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 revolutionsProcedure or surgery
The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 10 times
20 revolutionsProcedure or surgery
The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 20 times
| Study group | Role | What they receive |
|---|---|---|
| 10 revolutions | Experimental | In this group, 10 revolutions will be made with the EBUS-TBNA needle Receives: Procedure: 10 revolutions |
| 20 revolutions | Active comparator | In this group, 10 revolutions will be made with the EBUS-TBNA needle Receives: Procedure: 20 revolutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma
Measured: 1 week
Secondary outcomes (1)
Adequacy of samples as indicated by the presence of lymphocytes
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875756
- Sponsor's protocol ID
- NK/2232/study/1116
- Status last verified
- Aug 2018
- First submitted
- 18 Aug 2016
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
- ClinicalTrials.gov ID
- NCT02875756
- Acronym / sponsor ID
- NK/2232/study/1116
- Conditions
- Sarcoidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Aug 2016 (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 investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis.
Detailed description
Sarcoidosis is a multisystem disorder of unknown etiology characterized by granulomatous inflammation involving various body organs. The diagnosis is made on the basis of compatible clinicoradiological feature, histopathologic evidence of non-caseating granuloma, and exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling.
Among the bronchoscopic techniques, TBNA of lymph nodes has emerged as the most useful modality in addition to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA are well established. With improvements in technology, last decade has seen the use of EBUS to guide transbronchial needle aspiration. This technique is a minimally invasive and offers the additional advantage of choosing the appropriate node for sampling based on the vascularity, echogenicity and size. Studies subsequently have demonstrated the superiority EBUS-TBNA over conventional TBNA.
Once the role of TBNA in diagnostic bronchoscopy was clear, technical aspects of the procedure became the topic of research. This includes the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the distance travelled by the needle within the lymph node. The number of revolutions i.e. the number of times the needle should be moved back-and-forth inside the lymph node is one such factor. The recommendation is to move the needle ten to twenty times. However the optimum number of times the needle should be moved back and forth for extracting adequate tissue material has not been studied to date. The investigators have observed that performing revolutions during EBUS-TBNA frequently leads to aspiration of blood during the procedure.
The investigators hypothesize that the number of revolutions will not affect the diagnostic yield, and the yield would be similar in 10 compared to 20 revolutions. In this study, the investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of EBUS-TBNA in patients with sarcoidosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 revolutions | Experimental | Procedure: 10 revolutionsIn this group, 10 revolutions will be made with the EBUS-TBNA needle |
| 20 revolutions | Active comparator | Procedure: 20 revolutionsIn this group, 10 revolutions will be made with the EBUS-TBNA needle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age group of 18 to 65 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
Key exclusion criteria (4 listed)
- Hypoxemia (SpO2 <92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
- Failure to provide 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 |
|---|---|---|
| 10 revolutionsThe 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 10 times | Procedure or surgery | 10 revolutions |
| 20 revolutionsThe 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 20 times | Procedure or surgery | 20 revolutions |
Primary outcome
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma
Time frame: 1 week
1 secondary outcome
Adequacy of samples as indicated by the presence of lymphocytes
Time frame: 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 24 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Phase 2/3 study testing 10 revolutions and 20 revolutions in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 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 24 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 India. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma (time frame: 1 week). 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 24 Aug 2018.