Actively Recruiting
Multicenter Study on the 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hyperthyroidism is a condition caused by excessive thyroid hormone production, leading to increased metabolism and symptoms like weight loss, palpitations, and sweating. Traditional treatments include antithyroid drugs, radioactive iodine, and surgery, but each has limitations such as side effects, risk of recurrence, or complications. This research aims to evaluate the combined use of thermal ablation with antithyroid drugs as a promising approach to improve symptom control and long-term management in patients with primary hyperthyroidism. The study focuses on a combined treatment involving minimally invasive thermal ablation methods like radiofrequency or microwave ablation guided by ultrasound, alongside antithyroid drug therapy. Thermal ablation precisely destroys overactive thyroid tissue under local anesthesia, potentially reducing drug dosage and duration needed. This approach is intended to offer rapid symptom improvement with fewer side effects, minimal scarring, and cost advantages. The study will collect data from multiple centers to assess the effectiveness, safety, and factors influencing outcomes of this combined treatment. Participants will be monitored for up to three years, with evaluations including disease remission rates, thyroid volume changes, antibody levels, complication rates, and medication doses. Follow-up assessments will also track ablation volume ratio one month after treatment. The study involves informed consent and requires patients to have controlled heart rates and stable metabolic rates. Researchers aim to provide high-quality evidence to optimize therapy protocols and guide clinical use of this combined treatment strategy.
CONDITIONS
Brief Title
Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with primary hyperthyroidism based on clinical and laboratory findings
- Basal metabolic rate within ±20% of normal and resting heart rate controlled at 90 beats per minute or below
- Inadequate response or severe adverse reactions to antithyroid drug therapy, or unsuitable/unresponsive to radioactive iodine therapy
- Patients declining conventional surgery and opting for ablation combined with medication
- Patients with mild, moderate, or severe disease
- Patients with moderate-to-severe Graves' ophthalmopathy
- Patients with a safe needle path for ablation
- Patients able to understand the study purpose, willing to participate, and provide written informed consent
You will not qualify if you...
- Severe coagulopathy
- Poor general health including severe cardiac, liver, kidney, or 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 women, or planning pregnancy soon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with ongoing medication management as per routine care
Participants undergo thyroid thermal ablation combined with antithyroid drug therapy, where a minimally invasive heat-based procedure is performed alongside medication management.
1 procedure visit and ongoing medication visits as part of routine care
Duration - Up to 3 years
Participants are monitored over time to assess disease remission, thyroid volume changes, antibody levels, and medication dose adjustments following treatment.
Periodic visits for assessments over 3 years
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zeyu Yang, Postgraduate
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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