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

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

NCT ID: NCT06426563

Condition: Thyroid Nodule \(Benign\)
Ablation Therapy

Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases

Conditions: Keywords:
Ablation therapy
Thyroid nodule
benign
RFA
MWA

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Ablation treatment of thyroid nodule
Description: Use Radiofrequency or Microwave ablation device to treat thyroid nodule
Arm group label: Microwave ablation treatment (MWA) to thyroid nodule
Arm group label: Radiofrequency ablation treatment (RFA) to thyroid nodule

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: 00000
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Man Him, Matrix Fung, MBBS

Phone: +852-22554232
Email: mmhfung@hku.hk

Investigator:
Last name: Man Him, Matrix Fung, MBBS
Email: Principal Investigator

Start date: April 15, 2024

Completion date: June 30, 2028

Lead sponsor:
Agency: The University of Hong Kong
Agency class: Other

Source: The University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06426563