RecruitingNot ApplicableNCT06426563

MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules

Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial


Sponsor

The University of Hong Kong

Enrollment

150 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). \[1-3\] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules. Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized \[4-9\], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two minimally invasive procedures — microwave ablation (MWA) and radiofrequency ablation (RFA) — for treating medium-sized benign (non-cancerous) thyroid nodules. Both use heat to shrink the nodule, and the study aims to find out which works better. **You may be eligible if...** - You are 18 or older - You have a benign thyroid nodule that is at least 2 cm wide but less than 20 mL in volume - Your nodule is predominantly solid (at least 80% solid tissue) - The nodule has been confirmed as benign by two fine needle biopsies (or one biopsy plus low-suspicion ultrasound features) - Both functioning and non-functioning nodules are eligible **You may NOT be eligible if...** - Your nodule has indeterminate biopsy results - Your nodule extends behind the breastbone or into areas not visible by ultrasound - You are pregnant - You have a cardiac arrhythmia, pacemaker, or another condition that makes thermal ablation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAblation treatment of thyroid nodule

Use Radiofrequency or Microwave ablation device to treat thyroid nodule


Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong

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NCT06426563


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