Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer
Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Juliang Zhang
- Número de teléfono: 86+18792998965
- Correo electrónico: 408123913@qq.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Endoscopic assisted surgery
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Conventional open surgery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of complications
Periodo de tiempo: The observation period is at least 3 years from the start of enrollment
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The short-term complication rate of surgery in subjects includes postoperative infection, postoperative bleeding, temporary recurrent laryngeal nerve injury, superior laryngeal nerve injury, and temporary hypocalcemia or hypoparathyroidism; the long-term complication rate includes permanent recurrent laryngeal nerve injury and permanent hypocalcemia or hypoparathyroidism.
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The observation period is at least 3 years from the start of enrollment
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patient satisfaction
Periodo de tiempo: The assessment was conducted at 6, 12, and 24 months post-surgery
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The assessment was conducted using the Patient Scar Assessment Questionnaire (PSAQ).
This questionnaire comprises four valid subscales (totaling 29 items): Scar Appearance (10 items, scoring range 9-36), Scar-Related Self-Consciousness (6 items, scoring range 6-24), Satisfaction with Appearance (8 items, scoring range 8-32), and Satisfaction with Symptoms (5 items, scoring range 5-20).
Each item is scored using a four-point categorical response scale (1=most favorable, 4=least favorable).
A higher total score indicates more severe scar-related issues or lower satisfaction.
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The assessment was conducted at 6, 12, and 24 months post-surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease-free-survival
Periodo de tiempo: The observation period is at least 3 years from the start of enrollment
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The duration from the subject's enrollment to the first occurrence of recurrent disease, which includes ipsilateral lymph node recurrence, local or regional recurrence, distant recurrence, and death from any cause.
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The observation period is at least 3 years from the start of enrollment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XJYY-LL-FJ-029
- 82303359 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
- S2021-YF-YBSF-0258 (Otro número de subvención/financiamiento: Key R&D Program of Shaanxi Province)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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