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

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

Hyperthyroidism is a clinical syndrome caused by excessive production of thyroid hormones, leading to accelerated metabolism and increased excitability of multiple organ systems. Patients commonly present with polyphagia, weight loss, palpitations, and sweating. Primary hyperthyroidism is a common endocrine disorder traditionally treated with anti-thyroid drugs (ATD), radioactive iodine (¹³¹I), or surgery.

While ATD can rapidly inhibit thyroid hormone synthesis and control symptoms, long-term use carries risks of liver damage and bone marrow suppression. Radioactive iodine involves risks of recurrence or permanent hypothyroidism, and thyroidectomy-though effective-is associated with significant trauma, potential complications, and cervical scarring. Given the limitations of these monotherapies, a combined approach leveraging thermal ablation as an adjunct to antithyroid drug therapy has emerged as a promising strategy for both rapid symptom control and long-term management.

With advances in minimally invasive techniques, thermal ablation combined with pharmacotherapy offers a balanced solution. Thermal ablation-including microwave and radiofrequency ablation-provides high precision, minimal invasiveness, and rapid recovery by directly destroying hyperfunctioning thyroid tissue under ultrasound guidance. When paired with a tailored antithyroid drug regimen, this approach not only secures immediate stabilization of thyroid function but also reduces the required drug dosage and duration, thereby mitigating drug-related adverse effects. This combined strategy maintains the cosmetic and cost-effective advantages of ablation while addressing the need for sustained endocrine control.

Studies have demonstrated that thermal ablation combined with antithyroid drugs effectively normalizes T3 and T4 levels, alleviates hypermetabolic symptoms such as palpitations and sweating, and significantly improves quality of life with a low complication rate. This integrated model is suitable for initial treatment, recurrent or refractory cases, and is particularly advantageous for patients with reduced cardiopulmonary reserve or advanced age.

However, current evidence is largely derived from single-center studies, and high-quality multicenter data are needed to validate this combined strategy. This study aims to prospectively collect baseline data from patients undergoing thermal ablation in conjunction with antithyroid drug therapy across multiple centers. The objectives are to evaluate the efficacy and safety of this combined modality, explore the factors influencing the prognosis of ablation in a medicated context, optimize postoperative medication adjustment protocols, and provide high-quality evidence to guide the standardization and clinical dissemination of this synergistic approach.

Study Overview

• Status: Recruiting
• Conditions: Efficacy and Safety; Hyperthyroidism/Thyrotoxicosis; Complication Rate; Cure Rate
• Intervention / Treatment: Procedure: thermal ablation combined with antithyroid drug therapy

• Study Type: Observational
• Enrollment (Estimated): 454

Contacts and Locations

• Study Contact: Name: Zeyu Yang, Postgraduate; Phone Number: 8618518118526; Email: 987994761@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Zeyu Yang, Postgraduate; Phone Number: 8618518118526; Email: 987994761@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The population receiving thermal ablation combined with antithyroid drug therapy for hyperthyroidism primarily includes patients diagnosed with hyperthyroidism (e.g., Graves' disease, toxic multinodular goiter, or toxic adenomas). These patients typically choose this combined approach due to inadequate response or intolerance to antithyroid drugs alone, refusal of radioactive iodine, or unsuitability/unwillingness for surgery. The combined strategy aims to ablate hyperfunctioning tissue while maintaining stable thyroid function with medication, preserving normal glandular tissue, avoiding lifelong replacement therapy, and achieving minimal scarring, rapid recovery, and short hospitalization. Candidates generally have moderate thyroid volumes and localized lesions amenable to ultrasound-guided ablation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

thyroid thermal ablation combined with antithyroid drug therapy group; The hyperthyroidism thermal ablation combined with antithyroid drug therapy group refers to the cohort of patients with hyperthyroidism who undergo thermal ablation therapy-such as radiofrequency ablation or microwave ablation-in conjunction with antithyroid drug treatment. Patients enrolled in this group must meet clearly defined inclusion criteria and have indications for thermal ablation adjunctive to pharmacotherapy.

Procedure: thermal ablation combined with antithyroid drug therapy; Thyroid thermal ablation combined with antithyroid drug therapy is a multimodal approach wherein a minimally invasive procedure is integrated with pharmacologic management. The procedural component utilizes heat energy (such as radiofrequency or microwave) delivered through a thin needle inserted into hyperfunctioning thyroid tissue under ultrasound guidance. The heat induces coagulative necrosis of the target lesion, which is subsequently absorbed by the body. When employed as an adjunct to antithyroid drug therapy, this combined strategy leverages the precision, minimal invasiveness, and absence of scarring associated with ablation-typically performed under local anesthesia without open surgery-while allowing for optimized medication dosing and improved preservation of normal thyroid function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease remission rate	Disease remission rate refers to the proportion of patients in whom thermal ablation achieves the intended clinical outcomes in the treatment of hyperthyroidism, primarily reflected in three aspects: biochemical indicators, patient symptoms, and medication dosage. In terms of biochemical indicators, remission is manifested by the normalization of FT3, FT4, and TSH, reflecting improvement in thyroid function. In terms of patient symptoms, hyperthyroidism-related symptoms such as palpitations, tremor, heat intolerance, excessive sweating, weight loss, and irritability are significantly alleviated or resolved. In terms of medication dosage, patients are able to discontinue or reduce the dose of antithyroid drugs (such as methimazole or propylthiouracil) postoperatively while maintaining euthyroidism. Remission is achieved when all three criteria are met simultaneously.	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate	The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.	3-year
Change in thyroid volume	Measured immediately post-ablation, then at 1, 3, 6, and 12 months post-ablation, and every 6 months thereafter, reported as absolute volume (mL) change.	3-year
Thyroglobulin antibody	Change in TGAb levels from baseline post-ablation	3-year
Thyrotropin receptor antibody	Change in thyrotropin receptor antibody (TRAb) levels measured from baseline to post-ablation time points.	3-year
Ablation volume ratio	Defined as (ablated volume / total thyroid volume) × 100%, assessed by contrast-enhanced ultrasound at 1 month post-ablation, reported as percentage	1 month
Thyroid peroxidase antibody	Change in TPOAb levels from baseline post-ablation	3-year
Postoperative medication dose	Change in postoperative ATD dose from baseline to post-ablation, reported as daily dose (mg).	3-year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Thermal Ablation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hyperthyroidism; Thyrotoxicosis
• Other Study ID Numbers: S2025-050-01

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