Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 80
SponsorChinese PLA General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
thermal ablation combined with antithyroid drug therapy
Procedure/SurgeryThyroid 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.
Treatment groups
454 Participants
are divided into 1 treatment groupGroup A: thyroid thermal ablation combined with antithyroid drug therapy group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3-yearSecondary outcomes
1
complication rate
The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.
Time frame
3-year2
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.
Time frame
3-year3
Thyroglobulin antibody
Change in TGAb levels from baseline post-ablation
Time frame
3-year4
Thyrotropin receptor antibody
Change in thyrotropin receptor antibody (TRAb) levels measured from baseline to post-ablation time points.
Time frame
3-yearSponsors and contacts
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Source ClinicalTrials.gov