Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism

NCT06305871 | Active Not Recruiting

• 1 other identifier: 2023-NHLHCRF-YYPPLC-ZR-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared. The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study.

Conditions

Hyperthyroidism/Thyrotoxicosis

Keywords

Hyperthyroidism; Ultrasound-guided ablation

Outcome Measures

Primary Outcomes (2)

• Discontinuation rate

  Discontinuation rate in patients with hyperthyroidism ablation for six months after surgery

  two years

• Recurrence rate

  Recurrence rate in patients with hyperthyroidism ablation half a year after discontinuation of the drug

  two years

Study Arms (1)

Ablation group

EXPERIMENTAL

Patients with hyperthyroidism undergoing ultrasound-guided ablation

Procedure: Ablation therapy

Interventions

Ablation therapy PROCEDURE

Ablative treatment of hyperthyroidism

Ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Poor effect and recurrence after medical standard treatment
• serious adverse reaction to drug treatment
• poor effect of iodine-131 treatment
• Patients who wish to undergo ablation surgery to shorten the duration of treatment and improve symptoms
• Moderate to severe active Graves ophthalmopathy
• Second trimester patients

You may not qualify if:

• Poor general condition
• early and late pregnancy
• The retrosternal thyroid or thyroid gland is mostly behind the sternum
• Incomplete function of one vocal cord
• severe coagulation dysfunction
• Malignant exophthalmia
• Adolescent patients
• Patients requiring urgent relief of symptoms of oppression.

Sponsors & Collaborators

• Zhang Bo: lead

Study Sites (1)

China-Japan friendship hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Hyperthyroidism; Thyrotoxicosis

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 12, 2024
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)