Diagnostic Accuracy of Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples

Pusan National University

Status: Unknown

Conditions: Sarcoidosis; Tuberculosis; Lymphadenopathy

Treatments: Device: Nested PCR for fresh tissues; Device: Nested PCR for formalin-fixed tissues; Device: Real-time PCR for fresh tissues

Study type: Interventional

Funder types: Other

Identifiers

NCT02497079

PNUH-P-1

Details and patient eligibility

About

The purpose of this study is to compare the diagnostic efficacy of nested and realtime polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients with isolated intrathoracic lymphadenopathy.

Full description

Although endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been widely used to perform mediastinal lymph node sampling, little information is available on polymerase chain reaction for Mycobacterium tuberculosis (TB-PCR) using EBUS-TBNA samples in patients with isolated intrathoracic lymphadenopathy. In addition, two methods of TB-PCR (nested PCR and realtime PCR) are available for the detection of Mycobacterium tuberculosis and which method is superior for detection of Mycobacterium tuberculosis has not been established in patients with isolated intrathoracic lymphadenopathy.

Thus, this study was design to compare the diagnostic efficacy of nested and realtime TB-PCR using EBUS-TBNA samples in patients with isolated intrathoracic lymphadenopathy in South Korea, where the incidence of tuberculosis is intermediate (97/100,000 per year).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with isolated intrathoracic lymphadenopathy

Exclusion criteria

• Suspicion of primary lung cancer on CT or PET scan
• Suspicion of pulmonary tuberculosis on CT or PET scan
• Suspicion of sarcoidosis of lung parenchyma on CT or PET scan

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Nested PCR for formalin-fixed tissues

Experimental group

Description:

In all patients, nested polymerase chain reaction for Mycobacterium tuberculosis is performed with formalin-fixed paraffin-embedded specimens obtained by endobronchial ultrasound-guided transbronchial needle aspiration.

Treatment:

Device: Nested PCR for formalin-fixed tissues

Nested PCR for fresh tissues

Experimental group

Description:

In all patients, nested polymerase chain reaction for Mycobacterium tuberculosis is performed with specimens in sterile saline obtained by endobronchial ultrasound-guided transbronchial needle aspiration.

Treatment:

Device: Nested PCR for fresh tissues

Real-time PCR for fresh tissues

Experimental group

Description:

In all patients, real-time polymerase chain reaction for Mycobacterium tuberculosis is performed with specimens in sterile saline obtained by endobronchial ultrasound-guided transbronchial needle aspiration.

Treatment:

Device: Real-time PCR for fresh tissues