Evaluating two surgical methods for treating papillary thyroid cancer
A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.
This study is testing whether a new type of thyroid surgery without gas can be safer and more effective than traditional surgery for people with papillary thyroid cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05545852 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy compared to conventional open thyroidectomy for patients with papillary thyroid carcinoma. Participants will be randomly assigned to either the study group or the control group, and various outcomes will be measured, including complication rates, quality of life, and recurrence rates over three years. The study focuses on patients aged 18 to 70 with specific preoperative criteria to ensure optimal surgical results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of papillary thyroid carcinoma and specific preoperative staging criteria.
Not a fit: Patients with serious mental illness, pregnant or lactating individuals, or those with advanced disease involving multiple lobes or metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for patients with papillary thyroid cancer, potentially leading to quicker recovery times and improved quality of life.
How similar studies have performed: While there have been studies on endoscopic thyroidectomy, this specific approach is relatively novel and its success is yet to be fully established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Shangtong Lei, Dr. — Nanfang Hospital, Southern Medical University
- Study coordinator: Baihui Sun, Dr.
- Email: sunbh_nfyy@163.com
- Phone: +8602062787170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.