The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma

Официальное название

Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma

Обзор

Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy and is frequently associated with microscopic central neck lymph node metastases, even in the absence of preoperative clinical evidence of nodal involvement (cN0). While prophylactic central compartment neck dissection (pCCND) may improve staging accuracy and potentially reduce disease persistence or recurrence, its routine use remains controversial due to the risk of increased surgical morbidity and potential negligible impact on oncologic outcomes. This prospective randomized study aims to evaluate the oncological and surgical outcomes of cN0 PTC patients with tumors measuring 2 to 4 cm who undergo thyroid surgery with or without pCCND. Patients will be treated according to standard clinical practice with either total thyroidectomy (TT) or thyroid lobectomy (TL), and randomized to receive pCCND (bilateral or ipsilateral, respectively) or not. Patients undergoing TT and those undergoing TL will be analyzed separately in two parallel cohorts. The primary objective is to assess the impact of pCCND on disease persistence or recurrence during long-term follow-up. Secondary objectives include evaluation of surgical complications and the impact of pCCND on pathological staging.

Вмешательства

• Процедура Total Thyroidectomy + Central Compartment Neck Dissection
  Thyroidectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After the inferior laryngeal nerve and parathyroids are visualized, the thyroidectomy will be achieved. When performed, pCCND will aim at removing the nodes of Level VI, which has been reported to contain the thyroid gland and the adjacent nodes bordered superiorly by the h
• Процедура Thyroid Lobectomy + ipCCND
  Thyroid lobectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After identification and preservation of the inferior laryngeal nerve and parathyroid glands, thyroid lobectomy will be completed on the affected side. When performed, ipsilateral prophylactic central compartment neck dissection will aim at removing the lymph nodes of L

Первичные конечные точки

• Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma [Срок оценки: from enrollment to 1, 3, 5 and 10 years]
• Overall Survival [Срок оценки: from the enrollment to 1, 3, 5, and 10 years]

Вторичные конечные точки (2)

• Surgical Complications [Срок оценки: from enrollment to 1, 3, 5 and 10 years]
• Staging disease [Срок оценки: from enrollment to 1, 3, 5 and 10 years]

Критерии участия

Критерии включения

• PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \[16\]);
• patients scheduled for thyroid lobectomy or total thyroidectomy;
• no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
• no clinical evidence of distant metastasis at diagnosis;
• age ≥ 18 years;
• signing informed consent.

Критерии исключения

• histotypes other than PTC;
• evidence of lymph node metastases during surgery even if not previously diagnosed;
• presence of distant metastasis;
• refusal to sign informed consent.

Exit criteria:

• withdrawal of informed consent;
• post-operative radioactive iodine therapy.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06899347 · 27092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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