Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

Официальное название

Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules: a Prospective Multicentric Study

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Percutaneous radiofrequency ablation
  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. Th

Первичные конечные точки

• Health related Quality Of Life (HRQoL) [Срок оценки: 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]

Вторичные конечные точки (6)

• Symptom score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• > 18 years old
• 'Eastern Cooperative Oncology Group' (ECOG) performance status of 0 or 1
• Symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.
• No cutoff in nodule size.
• Solid component > 20%, and benign cytology (Bethesda II) in 1 (EUTIRADS 3) or 2 (EUTIRADS 4) separate cytological assessments. In the case of a proven "hot" nodule on scintigraphy, no biopsy is required.

Критерии исключения

• <18y
• Purely cystic nodule
• Severe comorbidity which limits the further life expectancy of the patient to < 2 years (opinion of the physician)
• Malignancies <2 years ago except for non-melanoma skin cancer and non-muscle invasive bladder cancer.
• Lack of compliance
• Malignant or suspicious thyroid nodules or nodules that are confluent in a compressive lobar mass
• Contralateral vocal cord paralysis
• Anticoagulant therapy that could not be suspended
• Unresolvable coagulation disorders
• Absence of consent of the patient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Бельгия · 3 центра

• AZ Sint-Jan Brugge — Bruges
• UZ Gent — Ghent
• UZ Leuven — Leuven

Публикации

• Shein-Chung Chow JS, Hansheng Wang, Yuliya Lokhnygina. Sample Size Calculations in Clinical Research. 3rd Edition ed2017.
• Nordqvist SF, Boesen VB, Rasmussen AK, Feldt-Rasmussen U, Hegedus L, Bonnema SJ, Cramon PK, Watt T, Groenvold M, Bjorner JB. Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO. Endocr Connect. 2021 Mar;10(3):316-324. doi: 10.1530/EC-21-0026. PMID 33617467
• Uslar V, Becker C, Weyhe D, Tabriz N. Thyroid disease-specific quality of life questionnaires - A systematic review. Endocrinol Diabetes Metab. 2022 Sep;5(5):e357. doi: 10.1002/edm2.357. Epub 2022 Jul 20. PMID 35856310
• Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26. PMID 26214034
• Reuters KB, Mamone MCOC, Ikejiri ES, Camacho CP, Nakabashi CCD, Janovsky CCPS, Yang JH, Andreoni DM, Padovani R, Maciel RMB, Vanderlei FAB, Biscolla RPM. Bethesda Classification and Cytohistological Correlation of Thyroid Nodules in a Brazilian Thyroid Disease Center. Eur Thyroid J. 2018 Jun;7(3):133-138. doi: 10.1159/000488104. Epub 2018 Apr 27. PMID 30023345
• Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5. PMID 28584945
• Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8. PMID 29167761
• Wang JF, Wu T, Hu KP, Xu W, Zheng BW, Tong G, Yao ZC, Liu B, Ren J. Complications Following Radiofrequency Ablation of Benign Thyroid Nodules: A Systematic Review. Chin Med J (Engl). 2017 Jun 5;130(11):1361-1370. doi: 10.4103/0366-6999.206347. PMID 28524837

Идентификаторы

NCT: NCT07237373 · ONZ-2025-0427

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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