Comparative Study of Transaxillary Robotic Thyroidectomy With MRND Versus Conventional Open Surgery in N1b PTC

Официальное название

Comparative Study of Transaxillary Robotic Thyroidectomy With Modified Radical Neck Dissection Versus Conventional Open Surgery in Patients With Papillary Thyroid Carcinoma and Lateral Neck Node Metastases: a Prospective Multicenter Randomized Controlled Study

Обзор

Thyroid cancer is one of the most common malignant tumors in women, ranking seventh in the United States and fourth in China. Papillary thyroid carcinoma is the most common pathological type (about 85% to 90% of thyroid cancers), and lateral cervical lymph node metastasis can reach 0.6-37.5% at diagnosis. For papillary thyroid cancer with lateral cervical lymph node metastasis, the 2015 ATA Guidelines in the United States recommend surgical resection and neck lymph node dissection as the primary treatment. Traditional cervical lymph node dissection often leaves obvious scars in the neck, which seriously affects the postoperative quality of life of patients. The previous studies have shown that endoscopy-assisted surgery with external cervical approach can achieve oncologic effects similar to traditional open surgery in the treatment of N1b papillary thyroid cancer, and can obtain better aesthetic results. However, endoscopic surgery still has some shortcomings, such as poor exposure of some surgical areas and difficult operation. Since November 2016, the investigators tried to apply modified transaxillary robotic-assisted surgery technology to the treatment of thyroid papillary carcinoma in China. The preliminary study included 30 patients, and the results showed that robot-assisted surgery via combined transaxillary-retroaural approach in the treatment of N1b papillary thyroid carcinoma achieved a good oncologic effect (5-year overall survival rate was 100.0%). As the surgical techniques improved, now the investigators can complete robotic-assisted lateral neck lymph node dissection via single-incision transaxillary approach. However, there is still a lack of high-quality evidence on the long-term oncologic outcome and quality of life of this procedure. In this study, a prospective, multi-center, randomized controlled study was conducted to compare the safety, long-term oncologic outcomes and postoperative quality of life of the robot-assisted surgery via single-incision transaxillary approach and open surgery in the treatment of N1b papillary thyroid cancer, which may provide an alternative for the patients with N1b papillary thyroid cancer.

Вмешательства

• Процедура robotic-assisted surgery
  robotic-assisted surgery via single-incision transaxillary approach
• Процедура Open Surgery
  conventional open surgery

Первичные конечные точки

• the disease-free survival rate [Срок оценки: 60 months]
• Postoperative quality of life：36-Item Short-Form Survey [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Overall survival（OS） [Срок оценки: 60 months]
• The dynamic change trend of shoulder function [Срок оценки: 60 months]
• The dynamic change trend of the postoperative quality of life [Срок оценки: 60 months]
• The dynamic change of swallowing function [Срок оценки: 60 months]
• The dynamic change trend of neck function [Срок оценки: 60 months]
• The dynamic change trend of aesthetic satisfaction [Срок оценки: 60 months]
• The dynamic change trend of voice function [Срок оценки: 60 months]

Критерии участия

Критерии включения

• Age 18-70 years old, male or female;
• papillary thyroid carcinoma with ipsilateral lateral cervical lymph node metastasis confirmed by FNAB;
• thyroid tumor of less than 3.0 cm in the largest diameter;
• lack of extrathyroidal extensions as estimated by preoperative ultrasonography and CT.

Критерии исключения

• level I or contralateral neck node metastases.
• enlarged lymph node of larger than 2.0 cm in the short diameter.
• suspected perinodal infiltration of metastatic lymph nodes.
• cervical or/and thoracic deformity.
• life-threatening diseases of liver, kidney, heart and other organs, or abnormal coagulation function.
• clinical evidence of distant metastases such as in the lung, bone, and so on.
• history of previous neck surgery and/or radiation therapy.
• intolerable to general anesthesia
• refuse either surgical procedure
• unwilling to cooperate with long-term follow-up evaluation.

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

Китай · 1 центр

• Sun Yat-sen Memorial Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06623578 · SYSKY-2024-495-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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