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Trial Title:
A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC
NCT ID:
NCT05545852
Condition:
Papillary Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Cancer, Papillary
Conditions: Keywords:
endoscopic
thyroidectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Description:
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph
Node Dissection
Arm group label:
Study Group
Intervention type:
Procedure
Intervention name:
COT(Conventional Open Thyroidectomy)
Description:
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Arm group label:
Control Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Baihui Sun, Dr.
Phone:
+8602062787170
Email:
sunbh_nfyy@163.com
Investigator:
Last name:
Shangtong Lei, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Tao Wei, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Chuanming Zheng, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Xin Lin, Dr.
Email:
Sub-Investigator
Start date:
June 1, 2021
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05545852
http://www.chictr.org.cn/showproj.aspx?proj=51290
