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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sarcoidosis
• Intervention / Treatment: Other: cTBNA without ROSE; Other: cTBNA with ROSE; Other: EBUS-TBNA without ROSE; Other: EBUS-TBNA with ROSE

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashesh Dhungana, MD; Phone Number: 00919953586175; Email: asheshdhungana12@gmail.com
• Study Contact Backup: Name: Randeep Guleria, DM; Phone Number: 00919810184738; Email: randeepguleria2002@yahoo.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110016
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Ashesh Dhungana, MD; Phone Number: 09953586175; Email: asheshdhungana12@gmail.com
      • Contact: Randeep Guleria, DM; Phone Number: 09810184738; Email: randeepg@hotmail.com
      • Principal Investigator: Ashesh Dhungana, MD
      • Principal Investigator: Randeep Guleria, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cTBNA without ROSE; Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy	Other: cTBNA without ROSE; Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
Other: cTBNA with ROSE; Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy	Other: cTBNA with ROSE; Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Other: EBUS-TBNA without ROSE; Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy	Other: EBUS-TBNA without ROSE; Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
Other: EBUS-TBNA with ROSE; Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy	Other: EBUS-TBNA with ROSE; Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis		6 months
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis		6 months
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis		6 months
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis		6 months
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis		6 months

Other Outcome Measures

Outcome Measure	Time Frame
Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis	6 months
Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis	6 months
Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis	6 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Principal Investigator: Ashesh Dhungana, MD, All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: June 7, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: DM Thesis