An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis (NCT04770948) | Clinical Trial Compass
CompletedNot Applicable
An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis
India150 participantsStarted 2021-03-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: All the following
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic yield of EBUS-TBNA samples
Timeframe: 6 months
Trial details
NCT IDNCT04770948
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh