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A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

Primary Purpose

Sarcoidosis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
cTBNA without ROSE
cTBNA with ROSE
EBUS-TBNA without ROSE
EBUS-TBNA with ROSE
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis
  • Significant mediastinal LAP (Short Axis Diameter more than 10mm)
  • Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis.
  • With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT).

Exclusion Criteria:

  • Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome)
  • Sarcoidosis Stage 3 and 4
  • Mediastinal Nodes less than 10 mm in short axis diameter
  • Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter
  • Those who received empiric Steroid for >2 weeks in preceding 3 months
  • Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia)
  • Unwilling to give consent

Sites / Locations

  • All India Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

cTBNA without ROSE

cTBNA with ROSE

EBUS-TBNA without ROSE

EBUS-TBNA with ROSE

Arm Description

Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Outcomes

Primary Outcome Measures

Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
Diagnostic Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage

Secondary Outcome Measures

Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis

Full Information

First Posted
June 7, 2015
Last Updated
July 6, 2015
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT02472808
Brief Title
A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
Official Title
Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.
Detailed Description
This study is investigator initiated, prospective, unblinded randomized study comparing conventional TBNA with EBUS-TBNA for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. It will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to Department of Pulmonary Medicine and Sleep Disorders in AIIMS (All India Institute of Medical Sciences), New Delhi. This study will help to know whether EBUS (Endobronchial Ultrasound guided) or conventional TBNA is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. It will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. It will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a 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
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cTBNA without ROSE
Arm Type
Other
Arm Description
Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Arm Title
cTBNA with ROSE
Arm Type
Other
Arm Description
Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Arm Title
EBUS-TBNA without ROSE
Arm Type
Other
Arm Description
Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Arm Title
EBUS-TBNA with ROSE
Arm Type
Other
Arm Description
Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Intervention Type
Other
Intervention Name(s)
cTBNA without ROSE
Intervention Description
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
Intervention Type
Other
Intervention Name(s)
cTBNA with ROSE
Intervention Description
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Intervention Type
Other
Intervention Name(s)
EBUS-TBNA without ROSE
Intervention Description
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
Intervention Type
Other
Intervention Name(s)
EBUS-TBNA with ROSE
Intervention Description
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Primary Outcome Measure Information:
Title
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
Description
Diagnostic Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
Description
Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
Time Frame
6 months
Title
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame
6 months
Title
Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis Significant mediastinal LAP (Short Axis Diameter more than 10mm) Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis. With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT). Exclusion Criteria: Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome) Sarcoidosis Stage 3 and 4 Mediastinal Nodes less than 10 mm in short axis diameter Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter Those who received empiric Steroid for >2 weeks in preceding 3 months Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia) Unwilling to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashesh Dhungana, MD
Phone
00919953586175
Email
asheshdhungana12@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Randeep Guleria, DM
Phone
00919810184738
Email
randeepguleria2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashesh Dhungana, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110016
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashesh Dhungana, MD
Phone
09953586175
Email
asheshdhungana12@gmail.com
First Name & Middle Initial & Last Name & Degree
Randeep Guleria, DM
Phone
09810184738
Email
randeepg@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ashesh Dhungana, MD
First Name & Middle Initial & Last Name & Degree
Randeep Guleria, DM

12. IPD Sharing Statement

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A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

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