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NCT Number: NCT06426563

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong, 00000

Location status: Recruiting

Location contact

Man Him, Matrix Fung, MBBS

CONTACT

[email protected]

+852-22554232

Man Him, Matrix Fung, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients >/=18 years of age
  • Nodule maximal diameter ≥2cm and nodule volume <20ml
  • Nodule being predominantly solid (≥80% solid)
  • 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
  • Both functional and non-functional nodules are eligible.

Exclusion criteria

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

Treatment and study plan

Ablation treatment of thyroid nodule

Procedure

Use Radiofrequency or Microwave ablation device to treat thyroid nodule

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. To measures nodule recurrence rate

    Time frame: 12-24 months

  2. To measures thyroid nodule regrowth rate

    Time frame: 12-24 months

  3. To measure cosmetic score by investigator (1-4)

    Time frame: 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)

  4. To measure the compressive symptom scores (from 0 - 100)

    Time frame: 12-24 months

    compressive symptom score from 0 (no compression feeling) to 100 (the most compressive)

  5. To measure swallowing impairment scores by questionnaire (SIS-6)

    Time frame: 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)

  6. To measure pain score (0-10) after ablation treatment

    Time frame: 12-24 months

    0 is no pain, 10 is the most painful

  7. Change of quality of life by SF12 ver 2

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Man Him, Matrix Fung, MBBS

CONTACT

[email protected]

+852-22554232

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 23, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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