RecruitingNCT07557810

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

Sponsor

Chinese PLA General Hospital

Enrollment

454 participants

Start Date

Feb 13, 2025

Study Type

OBSERVATIONAL

Conditions

Efficacy and Safety Hyperthyroidism/Thyrotoxicosis Complication Rate Cure Rate

Summary

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.

Eligibility

Max Age: 80 Years

Inclusion Criteria6

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 Criteria7

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.

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Interventions

PROCEDUREthermal 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.