Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer

Официальное название

Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer

Обзор

This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage. This study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years. After the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage. Establish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.

Первичные конечные точки

• Incidence of complications [Срок оценки: The observation period is at least 3 years from the start of enrollment]
• patient satisfaction [Срок оценки: The assessment was conducted at 6, 12, and 24 months post-surgery]

Вторичные конечные точки (1)

• Disease-free-survival [Срок оценки: The observation period is at least 3 years from the start of enrollment]

Критерии участия

Критерии включения

• Patients with newly diagnosed thyroid cancer aged ≥ 18 years and ≤ 70 years old;
• According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes.
• The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer;
• The surgical method is determined through joint consultation between the patient and the doctor;
• Participants voluntarily join this study and sign an informed consent form.

Критерии исключения

• Age>70 years old;
• Initial diagnosis of stage III-IV thyroid cancer;
• Thyroid cancer accompanied by abnormal thyroid function;
• The heart, lung, liver, kidney and other important organs have abnormal functions, and diabetes with poor control cannot tolerate surgery;
• The researcher believes that the patient is not suitable to participate in any other circumstances of this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07654322 · XJYY-LL-FJ-029 · 82303359 · S2021-YF-YBSF-0258

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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