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| ID | Type | Description | Link |
|---|---|---|---|
| 82303359 | Other Grant/Funding Number | National Natural Science Foundation of China | |
| S2021-YF-YBSF-0258 | Other Grant/Funding Number | Key R&D Program of Shaanxi Province |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic assisted surgery | |||
| Conventional open surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | 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. | The observation period is at least 3 years from the start of enrollment |
| patient satisfaction | 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. | The assessment was conducted at 6, 12, and 24 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free-survival | 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. | The observation period is at least 3 years from the start of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliang Zhang | Contact | 86+18792998965 | 408123913@qq.com |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |