Clinical trial NCT05861440: Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis
Official title: Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculous Lymphadenitis
Keywords: tuberculous lymphadenitis, paradoxical upgrading reaction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: reduction rate of paradoxical upgrading reaction
timeFrame: up to 9 months
Secondary outcomes:
measure: hospital-anxiety scale
timeFrame: up to 9 months
measure: hospital- depression scale
timeFrame: up to 9 months
measure: tuberculosis relapse rate
timeFrame: up to 24 months
measure: treatment duration
timeFrame: up to 9 months
measure: adverse events during corticosteroid therapy
timeFrame: up to 9 months
measure: paradoxical upgrading reaction rate in low elasticity group
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yen-Lin Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YL, Kuo YW, Wu HD, Wang JY, Wang HC. The application of ultrasound shear wave elastography in the prediction of paradoxical upgrading reaction in tuberculous lymphadenitis. a pilot study. J Formos Med Assoc. 2022 Sep;121(9):1696-1704. doi: 10.1016/j.jfma.2021.12.002. Epub 2021 Dec 23.
citation: Kuo YW, Chen YL, Wu HD, Chien YC, Huang CK, Wang HC. Application of transthoracic shear-wave ultrasound elastography in lung lesions. Eur Respir J. 2021 Mar 25;57(3):2002347. doi: 10.1183/13993003.02347-2020. Print 2021 Mar.