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Completed

NCT Number: NCT01908868

A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis

The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chest Clinic, PGIMER

Chandigarh, 160012, India

About this study

Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. In the past, TBLB has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of EBUS. We have observed that EBUS even though has high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

The study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration

Exclusion criteria

  • Pregnancy
  • Hypoxemia (SpO2 <90%) on room air
  • Poor lung function (forced expiratory volume in first second [FEV1] <1L)
  • Patients with deranged clotting profile (prothrombin time >3 seconds above control; activated partial thromboplastin time >10 seconds above control, platelet count <50000/µL)
  • Patients already initiated on glucocorticoids
  • Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent

Treatment and study plan

EBUS-TBNA

Other

Mediastinal and hilar lymph node aspiration using endobronchial ultrasound

Conventional TBNA

Other

Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration

Endobronchial and transbronchial biopsy

Other

Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Primary outcomes

  1. Diagnostic yield

    Time frame: 18 months

    The primary outcome is the diagnostic yield of the procedure defined as demonstration of granulomatous inflammation in two groups in patients finally labelled as sarcoidosis

Secondary outcomes

  1. Safety

    Time frame: 18 months

    Occurrence of serious adverse events (pneumothorax, bleeding >100 ml, death) in the two groups

  2. Diagnostic yield of individual sampling techniques

    Time frame: 18 months

    To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
Dec 30, 2014

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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