SarcoidosisNCT02459431
RCT Comparing 21 and 22 G Needle in the Diagnosis of Sarcoidosis by EBUS TBNA
A study testing 21 G needle group and 22 G needle group in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Randomized controlled trial to determine the efficacy of different needles sizes (22G and 21G) used in endobronchial ultrasound guided transbronchial needle aspiration Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- 21 G needle group and 22 G needle group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to Nov 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Clinicoradiological suspicion of sarcoidosis where endobronchial ultrasound guided transbronchial needle aspiration is contemplated
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
Who cannot join
- Hypoxemia (SpO2 <92%) on inspired fraction of oxygen 0.3
- Treatment with systemic glucocorticoids for more than 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
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: Impact of Needle Size on the Diagnosis of Sarcoidosis by Endobronchial Ultrasound Guided Transbronchial Needle Aspiration: Randomized Trial Comparing 21-Gauge and 22-Gauge Needles
Randomized controlled trial to determine the efficacy of different needles sizes (22G and 21G) used in endobronchial ultrasound guided transbronchial needle aspiration
Read the detailed description
Among the bronchoscopic techniques in diagnosis of sarcoidosis, transbronchial needle aspiration (TBNA) of lymph nodes has emerged as a particularly useful supplement to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA is well established. With improvements in technology, the last decade has seen the use of convex probe endobronchial ultrasonography (EBUS) to guide TBNA under direct vision. This technique is a minimally invasive alternative to mediastinoscopy, further it offers additional advantage of choosing the appropriate node for sampling on the basis of their echogenicity. Studies subsequently have demonstrated the superiority of EBUS TBNA over conventional TBNA.
Once the role of TBNA in diagnostic bronchoscopy was established, technical aspects of the procedure became the topic of research. Needle size used in TBNA is one such important factor. Apparently, larger the needle, better the tissue yield and hence improved diagnostic capability. Conventional TBNA is usually performed with a 19G needle, though varying sizes have been used in different studies (18, 21, 22, 26G). On the other hand, EBUS-TBNA is performed with a 22G needle. More recently 21G needles are being used for the same purpose. There have been conflicting reports in literature, when these two needle sizes have been compared with regards to the adequacy of the sample, accuracy of diagnosis and the rate of complications. Moreover, the above studies undertaken so far were done from centers where malignancy was the predominant diagnosis. Whether the needle size used during EBUS TBNA has any impact on diagnosing benign diseases like sarcoidosis is still not clear, hence this study was planned. The investigators hypothesize that performing EBUS-TBNA using 21G needles may enable identification of intact compact granulomas in sarcoidosis, and hence a better diagnostic yield than using a 22G needle.
- Conditions
- Sarcoidosis
- Being tested
- 21 G needle group, 22 G needle group
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21 G needle groupOther
Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 21 G needle, by random assignment
22 G needle groupOther
Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 22 G needle, by random assignment
| Study group | Role | What they receive |
|---|---|---|
| 21G needle group | Active comparator | 21 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration Receives: Other: 21 G needle group |
| 22G needle group | Active comparator | 22 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration Receives: Other: 22 G needle group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of EBUS TBNA with 21G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two
Measured: outcome assessed 6 months following enrollment of the last patient
Secondary outcomes (2)
Adequacy of samples
Samples will be considered adequate if the cytologic assessment shows lymphocytes and or definite if the specimen shows epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). The samples will be classified as: diagnostic, adequate but non-diagnostic, non-diagnostic and not adequate, no specimen
Measured: 0, 7, 180 days of inclusion
Complications
Complications encountered with both needle sizes will be compared if there is any difference in the rate of complications
Measured: 0, 7 , 180 days of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 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
- Investigators
- Ritesh Agarwal, DM, Principal investigator, Additional professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459431
- Sponsor's protocol ID
- PGIMERpulmoIndia
- Status last verified
- Jan 2017
- First submitted
- 26 May 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Needle Size on the Diagnosis of Sarcoidosis by Endobronchial Ultrasound Guided Transbronchial Needle Aspiration: Randomized Trial Comparing 21-Gauge and 22-Gauge Needles
- ClinicalTrials.gov ID
- NCT02459431
- Acronym / sponsor ID
- PGIMERpulmoIndia
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Jun 2015 (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.
Randomized controlled trial to determine the efficacy of different needles sizes (22G and 21G) used in endobronchial ultrasound guided transbronchial needle aspiration
Detailed description
Among the bronchoscopic techniques in diagnosis of sarcoidosis, transbronchial needle aspiration (TBNA) of lymph nodes has emerged as a particularly useful supplement to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA is well established. With improvements in technology, the last decade has seen the use of convex probe endobronchial ultrasonography (EBUS) to guide TBNA under direct vision. This technique is a minimally invasive alternative to mediastinoscopy, further it offers additional advantage of choosing the appropriate node for sampling on the basis of their echogenicity. Studies subsequently have demonstrated the superiority of EBUS TBNA over conventional TBNA.
Once the role of TBNA in diagnostic bronchoscopy was established, technical aspects of the procedure became the topic of research. Needle size used in TBNA is one such important factor. Apparently, larger the needle, better the tissue yield and hence improved diagnostic capability. Conventional TBNA is usually performed with a 19G needle, though varying sizes have been used in different studies (18, 21, 22, 26G). On the other hand, EBUS-TBNA is performed with a 22G needle. More recently 21G needles are being used for the same purpose. There have been conflicting reports in literature, when these two needle sizes have been compared with regards to the adequacy of the sample, accuracy of diagnosis and the rate of complications. Moreover, the above studies undertaken so far were done from centers where malignancy was the predominant diagnosis. Whether the needle size used during EBUS TBNA has any impact on diagnosing benign diseases like sarcoidosis is still not clear, hence this study was planned. The investigators hypothesize that performing EBUS-TBNA using 21G needles may enable identification of intact compact granulomas in sarcoidosis, and hence a better diagnostic yield than using a 22G needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 21G needle group | Active comparator | Other: 21 G needle group21 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration |
| 22G needle group | Active comparator | Other: 22 G needle group22 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Clinicoradiological suspicion of sarcoidosis where endobronchial ultrasound guided transbronchial needle aspiration is contemplated
- 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 inspired fraction of oxygen 0.3
- Treatment with systemic glucocorticoids for more than 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 |
|---|---|---|
| 21 G needle groupPatients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 21 G needle, by random assignment | Other | 21G needle group |
| 22 G needle groupPatients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 22 G needle, by random assignment | Other | 22G needle group |
Primary outcome
The diagnostic yield of EBUS TBNA with 21G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two
Time frame: outcome assessed 6 months following enrollment of the last patient
2 secondary outcomes
Adequacy of samples
Time frame: 0, 7, 180 days of inclusion
Complications
Time frame: 0, 7 , 180 days of inclusion
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 4 Jan 2017.
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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.
Ritesh Agarwal, DM principal investigator
Additional professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 21 G needle group and 22 G needle group 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 4 Jan 2017. 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.
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?
The diagnostic yield of EBUS TBNA with 21G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two (time frame: outcome assessed 6 months following enrollment of the last patient). 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 4 Jan 2017.