Actively Recruiting

Age: 0 - 80Years
All Genders
NCT07557810

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

Led by Chinese PLA General Hospital · Updated on 2026-04-29

454

Participants Needed

1

Research Sites

250 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with primary hyperthyroidism based on clinical signs and laboratory tests
  • Basal metabolic rate within ±20% of normal reference range
  • Resting heart rate controlled at 90 beats per minute or less
  • Inadequate response to standard antithyroid drug therapy or severe adverse reactions to these drugs
  • Unsuitable for or unresponsive to radioactive iodine therapy
  • Decline conventional surgery and prefer ablation combined with medication for rapid symptom improvement
  • Includes patients with mild, moderate, or severe disease
  • Presence of moderate-to-severe Graves' ophthalmopathy
  • Safe needle path available for ablation procedure
  • Able to understand study purpose, participate voluntarily, and provide informed consent
Not Eligible

You will not qualify if you...

  • Severe coagulopathy
  • Poor general health including severe heart, liver, kidney, or other major organ dysfunction
  • Substernal goiter or thyroid largely in retrosternal space (relative contraindication)
  • Malignant exophthalmos with risk of worsening after procedure
  • Significant tracheal compression needing urgent decompression
  • Unilateral vocal cord dysfunction confirmed by laryngoscopy
  • Women in first or third trimester of pregnancy, lactating, or planning pregnancy soon

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, China

Actively Recruiting

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Research Team

Z

Zeyu Yang, Postgraduate

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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