A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.

Conditions
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Papillary Thyroid Cancer

Intervention / Treatment
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* Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
* Procedure: COT(Conventional Open Thyroidectomy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient's informed consent; 18 years old < age < 70 years old; Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery; Color Doppler TI-RADS 4c-5 of primary thyroid tumor; The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging); It is expected that R0 surgical results can be obtained by performing single thyroid lobectomy and isthmus resection + ipsilateral central lymph node dissection; Preoperative ASA score I-III. Exclusion Criteria: Pregnant or lactating patients; Suffering from serious mental illness; Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes; Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis; Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function; History of neck surgery; History of thyroid surgery (including ablation therapy for thyroid nodules); Family history of thyroid cancer; History of childhood ionizing radiation exposure; History of other malignant diseases within 5 years; A history of unstable angina or myocardial infarction within 6 months; History of cerebral infarction or cerebral hemorrhage within 6 months; History of continuous systemic corticosteroid therapy within 1 month; Concurrent surgical treatment of other diseases is required; Patients who are judged by the investigator to be unsuitable to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection | Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)<br>* Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection<br>|
| Active Comparator: Control Group<br>Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection | Procedure: COT(Conventional Open Thyroidectomy)<br>* Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic, thyroidectomy