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

Not Applicable

• Conditions: Tuberculosis; Lymphadenopathy; Sarcoidosis
• Interventions: Device: Nested PCR for formalin-fixed tissues; Device: Nested PCR for fresh tissues; Device: Real-time PCR for fresh tissues

• Registration Number: NCT02497079
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed 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).

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-20
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with isolated intrathoracic lymphadenopathy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nested PCR for formalin-fixed tissues	Nested PCR for formalin-fixed tissues	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.
Nested PCR for fresh tissues	Nested PCR for fresh tissues	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.
Real-time PCR for fresh tissues	Real-time PCR for fresh tissues	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who detected each polymerase chain reactions for Mycobacterium tuberculosis	6 months	In all participants with isolated intrathoracic lymphadenopathy, three modalities of TB-PCR (nested PCR for formalin-fixed paraffin-embedded tissues, nested PCR for fresh tissues and real-time PCR for fresh tissues) are performed using EBUS-TBNA samples. The numbers of participants who reported as positive for each TB-PCR modalities are collected. From these data, sensitivity, specificity and diagnostic accuracy of each TB-PCR modalities to diagnose tuberculous lymphadenitis will be calculated.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of