Thermal ablation plus antithyroid medication for primary hyperthyroidism

Multicenter Study on the Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism

This trial tests whether adding thermal ablation to antithyroid drugs helps people with primary hyperthyroidism get faster symptom relief and fewer complications long term.

Quick facts

• Study type: Observational
• Enrollment: 454 (estimated)
• Ages: N/A to 80 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07557810 on ClinicalTrials.gov

What this trial studies

This observational study follows patients with primary hyperthyroidism who receive thermal ablation in combination with antithyroid drug therapy to document safety, symptom control, and cure rates. Participants are treated at a single center and monitored with clinical exams, thyroid hormone tests, and imaging over a defined follow-up period to record complications and recurrence. The study includes patients who have poor response or adverse reactions to standard drug therapy, are unsuitable for radioactive iodine, or decline surgery, and it documents procedural details and outcomes for real-world effectiveness data.

Who should consider this trial

Good fit: Ideal candidates are adults with primary hyperthyroidism who have controlled resting heart rate (≤90 bpm), BMR within ±20% of normal, and who have inadequate response to or cannot tolerate standard antithyroid drug therapy, are unsuitable for radioactive iodine, or decline surgery and have a safe needle path for ablation.

Not a fit: Patients whose thyroid anatomy is not amenable to safe ablation, who have uncontrolled cardiac conditions, or who have contraindications to antithyroid drugs or the procedure are unlikely to benefit from this combined approach.

Why it matters

Potential benefit: If successful, this approach could provide faster symptom control and reduce the need for surgery or repeated radioiodine while lowering long-term medication risks.

How similar studies have performed: Smaller clinical series and observational reports of thermal ablation for thyroid disease have shown promising symptom relief and reduced nodule burden, but large randomized trials combining ablation with antithyroid drugs are limited.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with primary hyperthyroidism based on clinical manifestations and laboratory findings;
* Patients whose basal metabolic rate (BMR) remains within ±20% of the normal reference range, and whose resting heart rate is controlled at ≤90 beats/min;
* Patients with inadequate response to standard antithyroid drug (ATD) therapy, those experiencing severe adverse reactions to ATDs, those unsuitable for or unresponsive to radioactive iodine (RAI) therapy, or those who decline conventional surgical resection and wish to undergo ablation combined with medication to shorten the treatment course and achieve rapid improvement of hyperthyroid symptoms, including patients with mild, moderate, or severe disease;
* Patients with concomitant moderate-to-severe Graves' ophthalmopathy (GO);
* Patients with a safe needle trajectory for ablation access;
* Patients who are able to understand the purpose of the study, voluntarily participate, and provide written informed consent.

Exclusion Criteria:

* Severe coagulopathy;
* Poor general condition, such as concomitant severe cardiac, hepatic, renal, or other major organ dysfunction;
* Substernal goiter or a thyroid gland largely located in the retrosternal space (relative contraindication; staged treatment may be considered);
* Patients with malignant exophthalmos in whom the condition may worsen post-procedure;
* Patients with significant tracheal compression requiring urgent decompression;
* Unilateral vocal cord dysfunction confirmed by laryngoscopy;
* Women in the first or third trimester of pregnancy, lactating women, or those planning pregnancy in the near future.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zeyu Yang, Postgraduate

Conditions Complication Rate; Efficacy and Safety; Hyperthyroidism/Thyrotoxicosis; Cure Rate; Thermal Ablation