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

NCT ID: NCT01908868

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS-TBNA

EBUS-TBNA (with endobronchial and transbronchial lung biopsy)

Group Type EXPERIMENTAL

EBUS-TBNA

Intervention Type OTHER

Mediastinal and hilar lymph node aspiration using endobronchial ultrasound

Endobronchial and transbronchial biopsy

Intervention Type OTHER

Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Conventional TBNA

Conventional TBNA (with endobronchial and transbronchial lung biopsy)

Group Type ACTIVE_COMPARATOR

Conventional TBNA

Intervention Type OTHER

Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration

Endobronchial and transbronchial biopsy

Intervention Type OTHER

Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Interventions

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EBUS-TBNA

Mediastinal and hilar lymph node aspiration using endobronchial ultrasound

Intervention Type OTHER

Conventional TBNA

Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration

Intervention Type OTHER

Endobronchial and transbronchial biopsy

Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Ritesh Agarwal

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chest Clinic, PGIMER

Chandigarh, , India

Site Status

Countries

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India

References

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Gupta D, Dadhwal DS, Agarwal R, Gupta N, Bal A, Aggarwal AN. Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014 Sep;146(3):547-556. doi: 10.1378/chest.13-2339.

Reference Type DERIVED
PMID: 24481031 (View on PubMed)

Other Identifiers

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1Trg/PG-2012/12563-601

Identifier Type: -

Identifier Source: org_study_id