Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
Primary Purpose
Sarcoidosis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
10 revolutions
20 revolutions
Sponsored by
About this trial
This is an interventional other trial for Sarcoidosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Post Graduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
10 revolutions
20 revolutions
Arm Description
In this group, 10 revolutions will be made with the EBUS-TBNA needle
In this group, 10 revolutions will be made with the EBUS-TBNA needle
Outcomes
Primary Outcome Measures
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma
Secondary Outcome Measures
Adequacy of samples as indicated by the presence of lymphocytes
Full Information
NCT ID
NCT02875756
First Posted
August 18, 2016
Last Updated
August 22, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02875756
Brief Title
Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
Official Title
A Study Evaluating the Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Sarcoidosis is a multisystem disorder of unknown etiology characterized by granulomatous inflammation involving various body organs. The diagnosis is made on the basis of compatible clinicoradiological feature, histopathologic evidence of non-caseating granuloma, and exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling.
Among the bronchoscopic techniques, TBNA of lymph nodes has emerged as the most useful modality in addition to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA are well established. With improvements in technology, last decade has seen the use of EBUS to guide transbronchial needle aspiration. This technique is a minimally invasive and offers the additional advantage of choosing the appropriate node for sampling based on the vascularity, echogenicity and size. Studies subsequently have demonstrated the superiority EBUS-TBNA over conventional TBNA.
Once the role of TBNA in diagnostic bronchoscopy was clear, technical aspects of the procedure became the topic of research. This includes the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the distance travelled by the needle within the lymph node. The number of revolutions i.e. the number of times the needle should be moved back-and-forth inside the lymph node is one such factor. The recommendation is to move the needle ten to twenty times. However the optimum number of times the needle should be moved back and forth for extracting adequate tissue material has not been studied to date. The investigators have observed that performing revolutions during EBUS-TBNA frequently leads to aspiration of blood during the procedure.
The investigators hypothesize that the number of revolutions will not affect the diagnostic yield, and the yield would be similar in 10 compared to 20 revolutions. In this study, the investigators plan to evaluate the effect of the number of needle revolutions inside the node on the diagnostic yield of EBUS-TBNA in patients with sarcoidosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 revolutions
Arm Type
Experimental
Arm Description
In this group, 10 revolutions will be made with the EBUS-TBNA needle
Arm Title
20 revolutions
Arm Type
Active Comparator
Arm Description
In this group, 10 revolutions will be made with the EBUS-TBNA needle
Intervention Type
Procedure
Intervention Name(s)
10 revolutions
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
20 revolutions
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Adequacy of samples as indicated by the presence of lymphocytes
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
State/Province
UT
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
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