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

Sarcoidosis Clinical Trial

Official title:

Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02472808
• Other study ID #: DM Thesis
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2015
• Last updated: July 6, 2015
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Ashesh Dhungana, MD
• Phone: 00919953586175
• Email: asheshdhungana12[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• cTBNA without ROSE
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
• cTBNA with ROSE
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
• EBUS-TBNA without ROSE
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
• EBUS-TBNA with ROSE
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis		6 months	Yes
Other	Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Other	Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis		6 months	Yes
Primary	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	6 months	Yes
Secondary	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	6 months	Yes
Secondary	Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis		6 months	Yes
Secondary	Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis		6 months	Yes