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To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) as the current standard surgical treatment mode in terms of feasibility and safety of radical thyroidectomy.
Subjects that suffering from papillary thyroid carcinoma will be randomized into Study Group (gasless transaxillary posterior endoscopic thyroidectomy ) or Control Group (conventional open thyroidectomy). Measure the outcomes as following, early complication rate, life quality score, the number of dissected lymph nodes, the volume of residual gland, 3-year recurrence rate, operation duration, hospital stays, hospitalization expense, and inflammatory and immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
|
| Control Group | Active Comparator | Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) | Procedure | Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early complication rate | Early complications include hemorrhage, surgical site infection, recurrent laryngeal nerve injury, hypoparathyroidism (PTH<15pg/ml, or showing hypocalcification symptoms), chyle leakage, trachea injury, esophageal injury, etc. | 30 days after surgery |
| Life quality score (3 days after surgery) | Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 days after surgery. | 3 days after surgery |
| Life quality score (1 month after surgery) | Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 month after surgery. | 1 month after surgery |
| Life quality score (3 months after surgery) | Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 months after surgery. | 3 months after surgery |
| Life quality score (6 months after surgery) | Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 6 months after surgery. | 6 months after surgery |
| Life quality score (1 year after surgery) | Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 year after surgery. | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The number of dissected lymph nodes | Record the number of harvest and metastatic lymph nodes. | 3 days after surgery |
| The volume of residual gland | Measure the volume of residual gland with ultrasound tests. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baihui Sun, Dr. | Contact | +8602062787170 | sunbh_nfyy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shangtong Lei, Dr. | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Label | URL |
|---|---|
| Registration on Chinese Clinical Trial Registry | View source |
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| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| COT(Conventional Open Thyroidectomy) | Procedure | Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection |
|
| 6 month after surgery |
| 3-year recurrence rate | The rate will be calculated from the day of randomization to the present of evidence of recurrence. | 3 years after surgery |
| Operation duration | Record the time from skin discission to incision close. | Intraoperative |
| Hospital stays | Record the days from the day of surgery to the day of discharge. | 3 days after surgery |
| Hospitalization expense | The total hospitalization expense. | 3 days after surgery |
| Inflammatory response | Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery. | 1 day after surgery |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |