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

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
EBUS-TBNA
Conventional TBNA
Endobronchial and transbronchial biopsy
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chest Clinic, PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EBUS-TBNA

Conventional TBNA

Arm Description

EBUS-TBNA (with endobronchial and transbronchial lung biopsy)

Conventional TBNA (with endobronchial and transbronchial lung biopsy)

Outcomes

Primary Outcome Measures

Diagnostic yield
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 Outcome Measures

Safety
Occurrence of serious adverse events (pneumothorax, bleeding >100 ml, death) in the two groups
Diagnostic yield of individual sampling techniques
To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB

Full Information

First Posted
July 16, 2013
Last Updated
December 26, 2014
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01908868
Brief Title
A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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
No

5. Study Description

Brief Summary
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
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.

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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA
Arm Type
Experimental
Arm Description
EBUS-TBNA (with endobronchial and transbronchial lung biopsy)
Arm Title
Conventional TBNA
Arm Type
Active Comparator
Arm Description
Conventional TBNA (with endobronchial and transbronchial lung biopsy)
Intervention Type
Other
Intervention Name(s)
EBUS-TBNA
Intervention Description
Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
Intervention Type
Other
Intervention Name(s)
Conventional TBNA
Intervention Description
Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
Intervention Type
Other
Intervention Name(s)
Endobronchial and transbronchial biopsy
Intervention Description
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
Primary Outcome Measure Information:
Title
Diagnostic yield
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Safety
Description
Occurrence of serious adverse events (pneumothorax, bleeding >100 ml, death) in the two groups
Time Frame
18 months
Title
Diagnostic yield of individual sampling techniques
Description
To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chest Clinic, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24481031
Citation
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.
Results Reference
derived

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

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