Actively Recruiting
MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules
Led by The University of Hong Kong · Updated on 2024-05-28
150
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older
- Nodule maximal diameter of at least 2 cm and nodule volume less than 20 ml
- Nodule is predominantly solid (80% or more solid)
- Nodules confirmed benign by either two benign fine needle biopsies within 1 year or one benign biopsy plus low suspicion ultrasound features
- Both functional and non-functional nodules are eligible
You will not qualify if you...
- Cytologically indeterminate nodules
- Nodules with substernal or posterior extension not visible well on ultrasound
- Current pregnancy or cardiac arrhythmias
- Presence of pacemaker or any medical condition making the patient unfit for thermal ablation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Queen Mary Hospital
Hong Kong, Hong Kong, 00000
Actively Recruiting
Research Team
M
Man Him, Matrix Fung, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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