Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

Not Applicable

Recruiting

• Conditions: Tuberculous Lymphadenitis
• Interventions: Drug: standard anti-tuberculosis agents; Drug: Prednisolone

• Registration Number: NCT05861440
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

1. To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis.

2. 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.

3. To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.

Detailed Description

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.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-05
• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-16
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participants diagnosed of tuberculous lymphadenitis.

• The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria:

  1. microbiological evidence (culture or nucleic acid amplification test)
  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care with standard anti-tuberculosis agent	standard anti-tuberculosis agents	standard anti-tuberculosis agent
Adjunct corticosteroid and standard anti-tuberculosis agent	standard anti-tuberculosis agents	Prednisolone dosing and duration per study protocol
Adjunct corticosteroid and standard anti-tuberculosis agent	Prednisolone	Prednisolone dosing and duration per study protocol

Primary Outcome Measures

Name	Time	Method
reduction rate of paradoxical upgrading reaction	up to 9 months	decreased in occurrence of unpredicted paradoxical reaction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan