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Thyroid cancer is one of the most common endocrine malignancies. In the past three decades, the incidence rate of thyroid cancer has continued to rise rapidly in many countries and regions around the world. The incidence rate of thyroid cancer in China is increasing year by year. The standardized incidence rate increased from 1.4/100000 person years in 1990 to 14.65/100000 person years in 2016. It has become the seventh malignant tumor in China with incidence rate, especially the incidence rate of women. Although differentiated thyroid cancer (DTC) has a low degree of malignancy, it still poses a threat to the life, health, and quality of life of patients. Due to its low mortality rate and long survival period, standardized diagnosis, treatment, and follow-up are even more necessary. The 5-year survival rate of thyroid cancer in China has increased significantly from 67.5% in 2003-2005 to 84.3% in 2012-2015, but still lags far behind the 98.3% in the United States.
The current treatment for thyroid cancer is mainly surgical treatment. The development concept of tumor surgery is first radical, followed by functional preservation, and finally aesthetic incision. Standardized and thorough radical surgery is the most critical link to improve patient prognosis and reduce the occurrence of complications. Lymph node metastasis is a common cause of patient recurrence. According to literature reports, the central lymph node metastasis rate after DTC surgery is 24% -64%, which affects the prognosis and quality of life of patients, often requiring secondary surgery, increasing the incidence of postoperative complications and patient burden. Therefore, thyroid cancer surgery requires standardized and thorough neck lymph node dissection. Based on surgical experience and autopsy research, several pre tracheal lymph nodes are often hidden in the deep surface of the thymus from the inferior pole of the thyroid to the upper edge of the unnamed artery. Postoperative recurrence of central lymph nodes often occurs in this area. Therefore, during the initial surgery, the neck segment of the thymus must be freed and pulled away to the shallow layer to thoroughly clean the pre tracheal lymph nodes hidden in the deep surface of the thymus. A considerable number of zone VII lymph nodes can also be pulled out to make the central lymph node cleaning more thorough. However, current surgical standards and guidelines do not emphasize the importance of thymus anatomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thymus anatomy | Experimental | Fine dissection and preservation of thymus tissue are required during surgery. |
|
| non-thymus anatomy | No Intervention | Conventional surgical method for central lymph node dissection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fine-dissection of the thymus | Procedure | In thyroid surgery, precise dissection and preservation of thymus tissue are used to improve the protection of the lower parathyroid gland function and increase the curative effect of the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of surgery | Count the number of central lymph node dissection and positive lymph nodes in routine pathological examination after surgery. Follow up neck ultrasound will be conducted at 3 months, 6 months, and 1 year after surgery, and then every 6 months. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| the PTH level after surgery | Dynamic monitoring of PTH changes will be conducted at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery until disease progression or recurrence or initiation of new anti-tumor treatment, whichever occurs first. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival situation | The disease-free survival (DFS) evaluated by IRC and researchers is defined as the time from the day of surgery to the first recorded occurrence of local or distant recurrence or death from any cause, whichever occurs first. Survival (OS) follow-up: After 30 days of treatment, a 3-month follow-up will be conducted to obtain survival information and subsequent anti-tumor treatment information of the subjects through telephone follow-up or other means, until death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor. |
Inclusion Criteria:
Hematology: Absolute neutrophil count (ANC) ≥ 1500/μ L; Platelets ≥ 100000/μ L; Hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L; Kidney: Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using the Cock Gault formula); Liver: For subjects with total bilirubin levels ≤ 1.5 × ULN or for subjects with total bilirubin levels>1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the subject still meets the inclusion criteria; Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects undergoing anticoagulant therapy as long as PT or aPTT is within the prescribed range of use of the anticoagulant drug; Willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan.
Exclusion Criteria:
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| 13 months |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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