A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

Papillary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545852
• Other study ID #: NFEC-2021-324
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Baihui Sun, Dr.
• Phone: +8602062787170
• Email: sunbh_nfyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papillary Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Neoplasms

Intervention

Procedure:
• GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
• COT(Conventional Open Thyroidectomy)
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The number of dissected lymph nodes	Record the number of harvest and metastatic lymph nodes.	3 days after surgery
Secondary	The volume of residual gland	Measure the volume of residual gland with ultrasound tests.	6 month after surgery
Secondary	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
Secondary	Operation duration	Record the time from skin discission to incision close.	Intraoperative
Secondary	Hospital stays	Record the days from the day of surgery to the day of discharge.	3 days after surgery
Secondary	Hospitalization expense	The total hospitalization expense.	3 days after surgery
Secondary	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

External Links

•   Registration on Chinese Clinical Trial Registry