An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis
NCT ID: NCT04770948
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2021-03-01
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
19G
19 gauge EBUS-TBNA needle
19 gauge needle
EBUS-TBNA performed using 19G needle
22G
22 gauge EBUS-TBNA needle
22 gauge needle
EBUS-TBNA performed using 22G needle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
19 gauge needle
EBUS-TBNA performed using 19G needle
22 gauge needle
EBUS-TBNA performed using 22G needle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
All India Institute of Medical Sciences
OTHER
Apollo Hospitals Enterprise Limited
OTHER
Jaipur Golden Hospital, New Delhi
UNKNOWN
Rajiv Gandhi Cancer Institute & Research Center, India
OTHER
Institute of Pulmonology, Medical Research, and Development, Mumbai
UNKNOWN
All India Institute of Medical Sciences, Bhopal
OTHER
Asian Institute of Gastroenterology, Hyderabad
UNKNOWN
Yashoda Hospitals, Hyderabad
UNKNOWN
City Clinic and Bhailal Amin General Hospital, Vadodara
UNKNOWN
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ritesh Agarwal
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PGIMER
Chandigarh, , India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPL822
Identifier Type: -
Identifier Source: org_study_id