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

Not Applicable

Recruiting

• Conditions: Thyroid Nodule \(Benign\); Ablation Therapy

• Registration Number: NCT06426563
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure	12 months

Secondary Outcome Measures

Name	Time	Method
To measures nodule recurrence rate	12-24 months
To measure cosmetic score by investigator (1-4)	12-24 months	To 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 months	compressive symptom score from 0 (no compression feeling) to 100 (the most compressive)
To measure swallowing impairment scores by questionnaire (SIS-6)	12-24 months	Swallowing 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)
Change of quality of life by SF12 ver 2	12-24 months	SF-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).
To measures thyroid nodule regrowth rate	12-24 months
To measure pain score (0-10) after ablation treatment	12-24 months	0 is no pain, 10 is the most painful

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong