Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculous Lymphadenitis
• Intervention / Treatment: Drug: Prednisolone; Drug: standard anti-tuberculosis agents

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Lin Chen; Phone Number: 0972651876; Email: moich1@ntuh.gov.tw
• Study Contact Backup: Name: Yen-Lin Chen; Phone Number: 0972651876; Email: moich.chen@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yen-lin Chen; Email: moich1@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yen-Lin Chen, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: tuberculous lymphadenitis, paradoxical upgrading reaction
• Additional Relevant MeSH Terms: Infections; Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis, Extrapulmonary; Tuberculosis; Lymphadenitis; Tuberculosis, Lymph Node; Physiological Effects of Drugs; Anti-Infective Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Bacterial Agents; Prednisolone; Antitubercular Agents
• Other Study ID Numbers: 202301222MINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No