A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Papillary Thyroid Cancer

Treatments: Procedure: COT(Conventional Open Thyroidectomy); Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05545852

NFEC-2021-324

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Study Group

Experimental group

Description:

Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Treatment:

Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)

Control Group

Active Comparator group

Description:

Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Treatment:

Procedure: COT(Conventional Open Thyroidectomy)