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Completed

NCT Number: NCT02875756

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Post Graduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10 revolutions

Procedure

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

20 revolutions

Procedure

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 outcomes

  1. Diagnostic yield of EBUS-TBNA as indicated by the presence of granuloma

    Time frame: 1 week

Secondary outcomes

  1. Adequacy of samples as indicated by the presence of lymphocytes

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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