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Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02875756
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Procedure: 10 revolutions Procedure: 20 revolutions Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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 Start Date : August 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: 10 revolutions
In this group, 10 revolutions will be made with the EBUS-TBNA needle
Procedure: 10 revolutions
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

Active Comparator: 20 revolutions
In this group, 10 revolutions will be made with the EBUS-TBNA needle
Procedure: 20 revolutions
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 Measures :
  1. Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Adequacy of samples as indicated by the presence of lymphocytes [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875756


Locations
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India
Post Graduate Institute of Medical Education and Research
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Ritesh Agarwal, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02875756     History of Changes
Other Study ID Numbers: NK/2232/study/1116
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Ivermectin
Selamectin
Antiparasitic Agents
Anti-Infective Agents