The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules. The main questions it aims to answer are: * Does RFA improve health-related quality of life (HRQoL) as measured by the ThyPRO-39 questionnaire? * Does RFA effectively reduce nodule volume and related symptoms (compressive or cosmetic)? Participants will: * Undergo a radiofrequency ablation procedure of the thyroid nodule performed under ultrasound guidance in an outpatient setting. * Complete quality of life questionnaires (ThyPRO-39) before treatment and at follow-up visits. Attend follow-up visits at 1, 3, 6, and 12 months with: * Ultrasound assessments of the thyroid nodule * Symptom and cosmetic scoring * Blood tests to monitor thyroid function * Safety checks for possible complications
Benign thyroid nodules are highly prevalent in the adult population. While most remain asymptomatic, some patients experience compressive symptoms, cosmetic concerns, or hyperthyroidism due to autonomously functioning nodules. Standard therapy is hemithyroidectomy or total thyroidectomy, which is effective but associated with risks such as hypothyroidism, nerve injury, visible scarring, and increased health care costs. As a result, minimally invasive, nonsurgical alternatives are being actively investigated. Radiofrequency ablation (RFA) is a percutaneous thermoablation technique performed under ultrasound guidance using a cooled electrode needle. Heat generated at the electrode tip induces localized necrosis within the target nodule, leading to progressive shrinkage while sparing surrounding thyroid tissue. In most cases, the procedure is carried out under local anesthesia in an outpatient setting, with an average duration of 15-40 minutes. The "moving shot" technique is typically employed, allowing precise ablation of large nodules in multiple overlapping steps. International guidelines from the European Thyroid Association (ETA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recommend RFA as an alternative for patients with benign thyroid nodules who present with compressive symptoms, cosmetic complaints, or autonomously functioning thyroid nodules not suitable for surgery or radioactive iodine. This multicenter prospective observational study will investigate the clinical effectiveness and safety of RFA in routine practice. The primary outcome is health-related quality of life (HRQoL), assessed by the validated ThyPRO-39 instrument. Secondary outcomes include technical efficacy (≥50% volume reduction rate), symptom and cosmetic improvement, stability of thyroid function, and safety endpoints based on the CIRSE classification of complications. Participants will undergo standardized baseline evaluation including ultrasound, cytology, and thyroid function testing. Follow-up visits are scheduled at 1, 3, 6, and 12 months, with systematic assessments of nodule characteristics, laboratory values, patient-reported outcomes, and complications. Technical success and regrowth will be defined according to internationally accepted thresholds. By collecting prospective multicenter data, this study aims to generate high-quality evidence on the role of RFA in the treatment of benign thyroid nodules. The results are expected to strengthen the scientific and economic case for adopting RFA as a reimbursable, minimally invasive therapy in clinical practice, while contributing to the long-term body of literature on patient-centered outcomes in thyroid disease.
Study Type
OBSERVATIONAL
Enrollment
50
RFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator ("moving shot" or "multiple overlapping shot" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis
AZ Sint-Jan Brugge
Bruges, Belgium
NOT_YET_RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGHealth related Quality Of Life (HRQoL)
HRQoL will be assessed by the change in Thyroid-Related Patient-Reported Outcome 39 (ThyPRO-39) score from baseline to 1-year follow-up. The ThyPRO-39 is a thyroid-specific quality of life instrument covering 13 domains of QoL validated for patients with benign thyroid disease. The ThyPRO-39 includes scales assessing the following: goiter symptoms, eye symptoms, hyperthyroid symptoms, hypothyroid symptoms, tiredness, cognitive complaints, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, appearance, and overall QoL. Each item is rated on a Likert scale (0-4) from 0 = "no symptoms/problems" to 4 = "severe symptoms/problems." Scores are then transformed to yield 13 0-100 scales, where a higher score indicates worse health-related QoL
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months
Symptom score
Registered on a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "no symptoms" and 10 indicates "worst imaginable symptoms".
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Cosmetic score
Assessed during physical examination; ranging from 1 to 4, where 1 graded as no palpable mass, 2 graded as a palpable mass without cosmetic issue, 3 graded as a cosmetic problem on swallowing, and 4 as a readily detected cosmetic problem.
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Number of Participants with Treatment-Related Adverse Events
Safety will be measured based on the presence of minor or major complications. Major and minor complications are those defined by the Society of Interventional Radiology.
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Volume Reduction Rate (VRR)
Calculated as VRR (%) = (initial volume - final volume) ÷ initial volume × 100
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Technical efficacy
Defined as a VRR ≥50%. Regrowth is defined as an increase in nodule volume to at least 150% of the minimum recorded volume during the follow-up period.
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Thyroid function
Evaluation of thyroid function, including serum TSH, free T4 (FT4), and free T3 (FT3) levels
Time frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
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