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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06426563
Enrollment
150
Registered
2024-05-23
Start date
2024-04-15
Completion date
2028-06-30
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablation Therapy, Thyroid Nodule \(Benign\)

Keywords

Ablation therapy, Thyroid nodule, benign, RFA, MWA

Brief 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.

Interventions

PROCEDUREAblation treatment of thyroid nodule

Use Radiofrequency or Microwave ablation device to treat thyroid nodule

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult patients \>/=18 years of age 2. Nodule maximal diameter ≥2cm and nodule volume \<20ml 3. Nodule being predominantly solid (≥80% solid) 4. Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound 5. Both functional and non-functional nodules are eligible.

Exclusion criteria

1. Cytologically indeterminate nodules 2. Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound 3. current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation

Design outcomes

Primary

MeasureTime frame
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure12 months

Secondary

MeasureTime frameDescription
To measures nodule recurrence rate12-24 months
To measures thyroid nodule regrowth rate12-24 months
To measure cosmetic score by investigator (1-4)12-24 monthsTo measure cosmetic score from 1 to 4 (1 is No palpable goitre, 2 is Palpable goitre but invisible, 3 is Goitre only visible to experienced clinician, 4 is Easily visible goitre)
To measure the compressive symptom scores (from 0 - 100)12-24 monthscompressive symptom score from 0 (no compression feeling) to 100 (the most compressive)
To measure swallowing impairment scores by questionnaire (SIS-6)12-24 monthsSwallowing Impairment Index (SIS-6) is an assessment tool about swallowing dysfunction and symptom. It comprises six question items ranging from 0 (no impairment) to 24 (maximum impairment)
To measure pain score (0-10) after ablation treatment12-24 months0 is no pain, 10 is the most painful
Change of quality of life by SF12 ver 212-24 monthsSF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life).

Countries

Hong Kong

Contacts

CONTACTMan Him, Matrix Fung, MBBS
mmhfung@hku.hk+852-22554232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026