Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

Study Overview
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Brief Summary
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To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis. To prospectively investigate the benefits of corticosteroid on reduction of paradoxical upgrading reaction in patients with tuberculous lymphadenitis based on the results of shear wave elastography. To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.

Detailed Description
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Tuberculosis remained one of the top ten leading cause of death worldwide. There were more than 10 million new diagnoses per year, and up to 1.2 million deaths caused by tuberculosis. Extra-pulmonary tuberculosis is defined as infection outside the lung. Tuberculous lymphadenitis is the most common site of extra-pulmonary tuberculosis, constituting around 30-50% of all cases. A unique manifestation with worsening of symptoms, called paradoxical upgrading reaction (PUR), may develop in 20-50% of patients with tuberculous lymphadenitis during the therapy. Common presentations of the PUR include swollen lymphadenitis with pain or rupture with pus. Patients may fail to complete the treatment and jeopardize the development of drug-resistant pathogen. Limited studies investigated the risk factors associated with the PUR. In our prior study, ultrasound shear wave elastography offers quantified values as the objective parameters to successfully predict the occurrence of PUR. In this study, we aim to investigate the effect of corticosteroid as an adjunct therapy to reduce the PUR from happening in patients with tuberculous lymphadenitis.

Official Title
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Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial

Conditions
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Tuberculous Lymphadenitis

Intervention / Treatment
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* Drug: Prednisolone
* Drug: standard anti-tuberculosis agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed of tuberculous lymphadenitis. The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria: microbiological evidence (culture or nucleic acid amplification test) histology specimen featuring caseating granulomatous inflammation with acid-fast bacilli on smear, or clinical response to anti-tuberculosis therapy. Exclusion Criteria: Participants with age < 18 years Diagnoses based on histologic report turned out to be non-tuberculosis mycobacterial infection The tuberculous lymphadenitis involved was surgically removed, without available target to be monitored Participant under systemic (oral or parenteral) steroid therapy. Participant with active hepatitis B virus infection Participant reluctant to be enrolled in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjunct corticosteroid and standard anti-tuberculosis agent<br>Prednisolone dosing and duration per study protocol | Drug: Prednisolone<br>* adjunct steroid per study protocol<br>Drug: standard anti-tuberculosis agents<br>* standard anti-tuberculosis agents<br>|
| Active Comparator: Standard of care with standard anti-tuberculosis agent<br>standard anti-tuberculosis agent | Drug: standard anti-tuberculosis agents<br>* standard anti-tuberculosis agents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction rate of paradoxical upgrading reaction | decreased in occurrence of unpredicted paradoxical reaction | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital-anxiety scale | The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety. | up to 9 months | 
| hospital- depression scale | The objective measurement of depression status by scoring, ranging from 0-21. Score with the higher value suggest more severe depression. | up to 9 months | 
| tuberculosis relapse rate | recurrence of tuberculosis infection | up to 24 months | 
| treatment duration | total duration of anti-tuberculosis drug | up to 9 months | 
| adverse events during corticosteroid therapy | any side effects of drugs related or associated with corticosteroid | up to 9 months | 
| paradoxical upgrading reaction rate in low elasticity group | the occurrence of paradoxical reaction in non-steroid using group | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tuberculous lymphadenitis, paradoxical upgrading reaction