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Набор скоро начнётся NCT07274605

Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid

Без фазы С лечением Thymectomy Thyroid Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Total thyroidectomy, Extended isthmusectomy.
Кому может быть актуально
Состояния в реестре: Thymectomy, Thyroid Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial.

Обзор

Prospective randomized open phase III non-inferiority trial in cT1bN0N1aM0 isthmus tumors of the thyroid comparing: extended Isthmusectomy (Isthmusectomy + Central Neck Dissection)(experimental group) versus total thyroidectomy + Central Neck Dissection (reference group).

Подробное описание

The thyroid isthmus is a narrow structure connecting the two lobes of the thyroid. Papillary carcinoma arising from this site accounts for only 1-9% of all thyroid cancers. However, due to its unique anatomical location, it is more prone to extranodal extension and bilateral lymph node metastasis, exhibiting more aggressive biological behavior. The optimal extent of surgery remains controversial: total thyroidectomy facilitates postoperative radioactive iodine therapy and monitoring but results in permanent dependence on thyroid hormone replacement and increases the risk of complications such as hypocalcemia, adversely affecting patients' quality of life. In contrast, conservative approaches like extended isthmusectomy can preserve partial thyroid function, reduce complications, and maintain a better quality of life, making them particularly suitable for low-risk patients with small tumors and no metastasis. Existing retrospective studies indicate no significant difference in recurrence rates between the two surgical approaches, though the evidence remains limited. Therefore, this study aims to conduct a prospective, multicenter, open-label, parallel-controlled, randomized trial to directly compare total thyroidectomy and extended isthmusectomy in terms of postoperative recurrence rates, quality of life, and complications, thereby providing high-quality evidence for surgical decision-making.

Вмешательства

  • Процедура Total thyroidectomy
    Total Thyroidectomy with bilateral central compartment (level VI) neck dissection - surgical removal of entire thyroid gland and perform bilateral Level VI neck dissection. This is the standard treatment recommended by the Chinese Guidelines for the Diagnosis and Management of Thyroid Nodules and Differentiated Thyroid Cancer (2nd Edition). The participating surgeons all routinely perform complete central neck dissections. They were selected for this study due to their standardized technique, w
  • Процедура Extended isthmusectomy
    Extended isthmusectomy with bilateral central compartment (level VI) neck dissection : Completely resect the isthmus and portions of the bilateral thyroid gland adjacent to the isthmus, ensuring an R0 resection margin for the tumor, while preserving at least more than half of the bilateral thyroid lobes.

Первичные конечные точки

  • Rate of 3-year recurrence [Срок оценки: maximum of 3 years after the surgery]
Вторичные конечные точки (5)
  • Anatomical location of tumor recurrence [Срок оценки: maximum of 3 years after the surgery]
  • Risk of surgical site recurrence [Срок оценки: maximum of 3 years after the surgery]
  • Health Related Quality of Life [Срок оценки: Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery]
  • Number of participants with Hormone Replacement Therapy [Срок оценки: 2-4 weeks and 3, 6, 12, 24, 36 months after the surgery]
  • Rate of surgical complications [Срок оценки: perioperatively, 2-4 weeks, 6 months after the surgery]

Критерии участия

Критерии включения

\- Age 18 years or older.

Diagnosis of low-risk differentiated thyroid cancer (papillary, follicular, or Hürthle cell carcinoma).

Unifocal tumor located in the thyroid isthmus, cT1b

No evidence of extrathyroidal extension, assessed by preoperative ultrasound.

Критерии исключения

\- Aggressive pathological subtypes (e.g., tall cell, clear cell, columnar cell, or diffuse sclerosing variants of papillary thyroid carcinoma, as well as poorly differentiated types).

cN1b.

M1

Combined with other suspicious thyroid nodules within the lobes.

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу

Идентификаторы

NCT: NCT07274605 · 2025-1245

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗