An observational study in Complication Rate, Efficacy and Safety and Hyperthyroidism/Thyrotoxicosis, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Chinese PLA General Hospital · Observational
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.
21 studies on the registry are indexed under Thyrotoxicosis; 5 are open to participants now.
This study's planned enrollment of 454 is above the median of 66 across 13 observational studies indexed under Thyrotoxicosis.
Browse Thyrotoxicosis studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Compared within Thyrotoxicosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperthyroidism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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-year
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-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.
Time frame: 3-year
Thyroglobulin antibody
Change in TGAb levels from baseline post-ablation
Time frame: 3-year
Thyrotropin receptor antibody
Change in thyrotropin receptor antibody (TRAb) levels measured from baseline to post-ablation time points.
Time frame: 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
Time frame: 1 month
Thyroid peroxidase antibody
Change in TPOAb levels from baseline post-ablation
Time frame: 3-year
Postoperative medication dose
Change in postoperative ATD dose from baseline to post-ablation, reported as daily dose (mg).
Time frame: 3-year
Plan to share: No
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