Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
A Study Evaluating the Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 18, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 24, 2018
August 1, 2018
1.3 years
August 18, 2016
August 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma
1 week
Secondary Outcomes (1)
Adequacy of samples as indicated by the presence of lymphocytes
1 week
Study Arms (2)
10 revolutions
EXPERIMENTALIn this group, 10 revolutions will be made with the EBUS-TBNA needle
20 revolutions
ACTIVE COMPARATORIn this group, 10 revolutions will be made with the EBUS-TBNA needle
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Additional Professor
Study Record Dates
First Submitted
August 18, 2016
First Posted
August 23, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 24, 2018
Record last verified: 2018-08