SarcoidosisGUESSNCT04770948
An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis
A study testing 19 gauge needle and 22 gauge needle in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- 19 gauge needle and 22 gauge needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2021to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged bilateral hilar and/or mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
- Ability to provide informed consent to participate in the study.
- Exclusion Criteria: Patients with any of the following will be excluded
- Asymmetric lymph nodes
Show all 12Show fewer
- Lymph nodes with significant hypodense areas suggestive of necrosis
- Tuberculin skin test >10 mm
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating the Diagnostic Yield and Safety of the 19-GaUge vs 22-Gauge EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis (GUESS)
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. In the presence of intrathoracic lymph nodes, transbronchial needle aspiration (TBNA) is a useful diagnostic modality, which is now guided using endobronchial ultrasound (EBUS).
We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
Read the detailed description
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The disease is diagnosed based on a suggestive clinicoradiological picture and the presence of non-caseating granulomas in the involved organ, after excluding known causes of granulomatous inflammation. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. Various bronchoscopic techniques such as endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are commonly used for acquiring tissue samples.
In the presence of intrathoracic lymph nodes, TBNA is a useful diagnostic modality, especially when combined with endobronchial and transbronchial biopsies. At most centers, TBNA is now guided using endobronchial ultrasound (EBUS). The technique is minimally invasive and also offers the advantage of a selection of the appropriate node for sampling based on the ultrasonographic characteristics. Several studies have demonstrated the superiority of EBUS-TBNA over conventional TBNA (TBNA performed without real-time guidance).
Several technical aspects of EBUS-TBNA have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, the distance travelled by the needle within the lymph node, the number of needle agitations required during a pass, and others.
The novel 19-G Vizishot FLEX EBUS needle (Olympus) is composed of a more flexible material (nitinol) than the 22-G EBUS needle. This allows it to have a larger inner diameter with the same outer diameter as a 22-G EBUS needle. Recent studies have shown that the 19-G needle is safe and has a comparable yield to smaller bore needles. In case of suspected lymphadenopathy due to malignant disorders, aspiration using smaller gauge needles may yield sufficient material for diagnosis. However, in sarcoidosis, larger nodal tissue obtained with a thicker bore needle, the 19-gauge needle, may potentially increase the identification of granulomas. We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- 19 gauge needle, 22 gauge needle
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 gauge needleDevice
EBUS-TBNA performed using 19G needle
22 gauge needleDevice
EBUS-TBNA performed using 22G needle
| Study group | Role | What they receive |
|---|---|---|
| 19G | Experimental | 19 gauge EBUS-TBNA needle Receives: Device: 19 gauge needle |
| 22G | Active comparator | 22 gauge EBUS-TBNA needle Receives: Device: 22 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of EBUS-TBNA samples
Specimen showing epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body).
Measured: 6 months
Secondary outcomes (4)
Adequacy of EBUS-TBNA samples
Specimen shows a preponderance of lymphocytes or is diagnostic
Measured: 7 days
Complication rate
Complication associated with EBUS-TBNA procedure
Measured: 7 days
Cough visual analog scale (VAS)
Operator-rated visual analog scale (VAS) score for the intensity of subject's cough
Measured: 1 day
Operator VAS
VAS score for ease of performance of the needle puncture and aspiration rated by the operator
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Mar 2021
- Primary completion28 Feb 2023
- Study completion30 Sep 2023
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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Apollo Hospitals Enterprise Limited, Jaipur Golden Hospital, New Delhi, Rajiv Gandhi Cancer Institute & Research Center, India, Institute of Pulmonology, Medical Research, and Development, Mumbai, All India Institute of Medical Sciences, Bhopal, Asian Institute of Gastroenterology, Hyderabad, Yashoda Hospitals, Hyderabad, City Clinic and Bhailal Amin General Hospital, Vadodara
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770948
- Sponsor's protocol ID
- SPL822
- Acronym
- GUESS
- Status last verified
- Nov 2023
- First submitted
- 22 Feb 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Diagnostic Yield and Safety of the 19-GaUge vs 22-Gauge EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis (GUESS)
- ClinicalTrials.gov ID
- NCT04770948
- Acronym / sponsor ID
- GUESS / SPL822
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Apollo Hospitals Enterprise Limited, Jaipur Golden Hospital, New Delhi, Rajiv Gandhi Cancer Institute & Research Center, India, Institute of Pulmonology, Medical Research, and Development, Mumbai, All India Institute of Medical Sciences, Bhopal, Asian Institute of Gastroenterology, Hyderabad, Yashoda Hospitals, Hyderabad, City Clinic and Bhailal Amin General Hospital, Vadodara
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- 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.
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. In the presence of intrathoracic lymph nodes, transbronchial needle aspiration (TBNA) is a useful diagnostic modality, which is now guided using endobronchial ultrasound (EBUS).
We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
Detailed description
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The disease is diagnosed based on a suggestive clinicoradiological picture and the presence of non-caseating granulomas in the involved organ, after excluding known causes of granulomatous inflammation. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. Various bronchoscopic techniques such as endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are commonly used for acquiring tissue samples.
In the presence of intrathoracic lymph nodes, TBNA is a useful diagnostic modality, especially when combined with endobronchial and transbronchial biopsies. At most centers, TBNA is now guided using endobronchial ultrasound (EBUS). The technique is minimally invasive and also offers the advantage of a selection of the appropriate node for sampling based on the ultrasonographic characteristics. Several studies have demonstrated the superiority of EBUS-TBNA over conventional TBNA (TBNA performed without real-time guidance).
Several technical aspects of EBUS-TBNA have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, the distance travelled by the needle within the lymph node, the number of needle agitations required during a pass, and others.
The novel 19-G Vizishot FLEX EBUS needle (Olympus) is composed of a more flexible material (nitinol) than the 22-G EBUS needle. This allows it to have a larger inner diameter with the same outer diameter as a 22-G EBUS needle. Recent studies have shown that the 19-G needle is safe and has a comparable yield to smaller bore needles. In case of suspected lymphadenopathy due to malignant disorders, aspiration using smaller gauge needles may yield sufficient material for diagnosis. However, in sarcoidosis, larger nodal tissue obtained with a thicker bore needle, the 19-gauge needle, may potentially increase the identification of granulomas. We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19G | Experimental | Device: 19 gauge needle19 gauge EBUS-TBNA needle |
| 22G | Active comparator | Device: 22 gauge needle22 gauge EBUS-TBNA needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age at least 18 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged bilateral hilar and/or mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
- Ability to provide informed consent to participate in the study.
- Exclusion Criteria: Patients with any of the following will be excluded
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 19 gauge needleEBUS-TBNA performed using 19G needle | Device | 19G |
| 22 gauge needleEBUS-TBNA performed using 22G needle | Device | 22G |
Primary outcome
Diagnostic yield of EBUS-TBNA samples
Time frame: 6 months
Specimen showing epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body).
4 secondary outcomes
Adequacy of EBUS-TBNA samples
Time frame: 7 days
Complication rate
Time frame: 7 days
Cough visual analog scale (VAS)
Time frame: 1 day
Operator VAS
Time frame: 1 day
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 29 Nov 2023.
- 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 study testing 19 gauge needle and 22 gauge needle 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 12 inclusion and 0 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 29 Nov 2023. 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?
Diagnostic yield of EBUS-TBNA samples (time frame: 6 months). 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 29 Nov 2023.