Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

Официальное название

Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated with Hemithyroidectomy or Radiofrequency Ablation.

Обзор

This is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment. The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.

Вмешательства

• Процедура Radiofrequency ablation alone
  RFA of a cancer in the thyroid gland.
• Процедура Surgery
  Hemithyroidectomy of the thyroid lobe with cancer

Первичные конечные точки

• Uncomplicated initial treatment (yes/no) [Срок оценки: One month after randomization.]

Вторичные конечные точки (5)

• Oncologic [Срок оценки: 5 years after randomization.]
• Endocrinological 1 [Срок оценки: At three months, 1, 2, 3, 4 and 5 years after randomization.]
• Patient-reported outcome 1 [Срок оценки: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.]
• Health economics [Срок оценки: At 5 years after randomization.]
• Patient-reported outcome 2 [Срок оценки: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.]

Критерии участия

Критерии включения

• Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
• tumor size of less than 2 cm in all dimensions.

Критерии исключения

• suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
• tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR
• if the patient is pregnant OR
• If the patient is unable to give informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Department of Otorhinolaryngology, Aarhus University Hospital — Aarhus

Идентификаторы

NCT: NCT06796348 · RFARCT8200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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