Tuberculosis Clinical Trial
Official title:
Comparison of the Diagnostic Accuracy of Nested and Real-time Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples in Patients With Isolated Intrathoracic Lymphadenopathy
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.
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).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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