Using Shear Wave Elastography and Steroids to Treat Tuberculous Lymphadenitis
Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
This study is testing if using steroids can help people with tuberculous lymphadenitis feel better by reducing worsening symptoms during treatment and is also looking for signs in the body that could predict these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05861440 on ClinicalTrials.gov |
What this trial studies
This study aims to collect radiologic data from patients with tuberculous lymphadenitis throughout their treatment process. It will investigate the effectiveness of corticosteroids in reducing paradoxical upgrading reactions, which can worsen symptoms during therapy. Additionally, the study seeks to identify potential biomarkers of host immunity that could predict these adverse reactions. By utilizing shear wave elastography, the study will provide objective measurements to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with tuberculous lymphadenitis who meet specific microbiological or histological criteria.
Not a fit: Patients under 18 years old or those with non-tuberculosis mycobacterial infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with tuberculous lymphadenitis by reducing the incidence of paradoxical upgrading reactions.
How similar studies have performed: Limited studies have explored similar approaches, but prior research indicates that shear wave elastography may effectively predict paradoxical upgrading reactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yen-Lin Chen — National Taiwan University Hospital
- Study coordinator: Yen-Lin Chen
- Email: moich1@ntuh.gov.tw
- Phone: 0972651876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.