A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

Not Applicable

Recruiting

• Conditions: Papillary Thyroid Cancer
• Interventions: Procedure: COT(Conventional Open Thyroidectomy); Procedure: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)

• Registration Number: NCT05545852
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	COT(Conventional Open Thyroidectomy)	Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Study Group	GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)	Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Primary Outcome Measures

Name	Time	Method
Life quality score (1 month after surgery)	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.
Life quality score (1 year after surgery)	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.
Early complication rate	30 days after surgery	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.
Life quality score (6 months after surgery)	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.
Life quality score (3 days after surgery)	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.
Life quality score (3 months after surgery)	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.

Secondary Outcome Measures

Name	Time	Method
The volume of residual gland	6 month after surgery	Measure the volume of residual gland with ultrasound tests.
Inflammatory response	1 day after surgery	Examine the white blood cell count (WBC), neutrophil count (NEU) and c-reactive protein (CRP) 1 day after surgery.
The number of dissected lymph nodes	3 days after surgery	Record the number of harvest and metastatic lymph nodes.
Operation duration	Intraoperative	Record the time from skin discission to incision close.
Hospitalization expense	3 days after surgery	The total hospitalization expense.
3-year recurrence rate	3 years after surgery	The rate will be calculated from the day of randomization to the present of evidence of recurrence.
Hospital stays	3 days after surgery	Record the days from the day of surgery to the day of discharge.

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China