Complication RateNCT07557810
Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
An observational study of Complication Rate and Efficacy and Safety, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Complication Rate, Efficacy and Safety, Hyperthyroidism/Thyrotoxicosis
- What is being tested?
- thermal ablation combined with antithyroid drug therapy
- Type of treatment
- Surgery or procedure
- How many people
- 454 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Zeyu Yang, Postgraduate, 8618518118526, 987994761@qq.com
About this study
Official title: Multicenter Study on the Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
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.
Read more
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.
- Being tested
- thermal ablation combined with antithyroid drug therapy
- Keywords
- Thermal Ablation
- Medical subject headings
- Hyperthyroidism, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal ablation combined with antithyroid drug therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| thyroid thermal ablation combined with antithyroid drug therapy group | 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. Receives: Procedure: thermal ablation combined with antithyroid drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-year
Secondary outcomes (7)
complication rate
The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.
Measured: 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.
Measured: 3-year
Thyroglobulin antibody
Change in TGAb levels from baseline post-ablation
Measured: 3-year
Thyrotropin receptor antibody
Change in thyrotropin receptor antibody (TRAb) levels measured from baseline to post-ablation time points.
Measured: 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
Measured: 1 month
Thyroid peroxidase antibody
Change in TPOAb levels from baseline post-ablation
Measured: 3-year
Postoperative medication dose
Change in postoperative ATD dose from baseline to post-ablation, reported as daily dose (mg).
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start13 Feb 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication RateStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557810
- Sponsor's protocol ID
- S2025-050-01
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
- ClinicalTrials.gov ID
- NCT07557810
- Acronym / sponsor ID
- S2025-050-01
- Keywords
- Thermal Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thyroid thermal ablation combined with antithyroid drug therapy group | – | Procedure: thermal ablation combined with antithyroid drug therapyThe 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermal ablation combined with antithyroid drug therapyThyroid 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. | Procedure or surgery | thyroid thermal ablation combined with antithyroid drug therapy group |
Primary outcome
Disease remission rate
Time frame: 3-year
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.
7 secondary outcomes
complication rate
Time frame: 3-year
Change in thyroid volume
Time frame: 3-year
Thyroglobulin antibody
Time frame: 3-year
Thyrotropin receptor antibody
Time frame: 3-year
Ablation volume ratio
Time frame: 1 month
Thyroid peroxidase antibody
Time frame: 3-year
Postoperative medication dose
Time frame: 3-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication Rate and Efficacy and Safety, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeyu Yang, Postgraduate (8618518118526, 987994761@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease remission rate (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.