Papillary thyroid carcinoma
Conditions
Interventions
Surgery Group:At least a complete lobectomy on the affected side, including the isthmus, combined with lymph node dissection in the tracheoesophageal groove on the affected side.
Thermal ablation group:Ultrasound-guided percutaneous thermal ablation therapy
Active surveillance group:Active surveillance
Sponsors
Fudan University Shanghai Cancer Center.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet all of the following criteria: 1. Age: 18 years or older, with no gender restrictions; 2. Papillary carcinoma confirmed by cytological examination; 3. Ultrasound indicates a single suspicious malignant nodule within the thyroid gland, with a diameter of =5 mm; for nodules not close to the capsule on all sides, this can be relaxed to a diameter of 5 mm), and there is no extraglandular invasion; 5. Patients voluntarily participate in this study and independently choose the intervention method, and have signed the Informed Consent Form (ICF); those with good expected compliance who can follow the protocol requirements for follow-up of therapeutic effects and adverse reactions.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Follicular thyroid carcinoma; 2. High-risk subtypes of papillary thyroid carcinoma (e.g., tall cell, insular, or columnar cell carcinoma); 3. Other histological subtypes of thyroid cancer (e.g., lymphoma, sarcoma, medullary carcinoma, or anaplastic carcinoma); 4. Suspected metastatic cervical lymph nodes or clinically suspected distant metastasis (to organs such as lung, bone, or brain) at initial diagnosis; 5. Presence of coarse calcifications within the thyroid microcarcinoma; 6. Confirmed evidence of lymph node or distant metastasis; 7. Family history of thyroid cancer; 8. History of neck radiation exposure during adolescence or childhood; 9. Concurrent hyperthyroidism; 10. Presence of intermediate-risk or multiple gene mutations associated with poor prognosis detected during genetic screening performed at the time of cytological puncture; 11. Severe coagulation disorder; 12. Severe cardiopulmonary disease; 13. History of neck irradiation; 14. Implantation of a cardiac pacemaker or presence of metallic stents within the body; 15. Severe or uncontrolled infection, or wounds failing to heal after 8 weeks of standard care; 16. Any condition deemed by the investigator as potentially harmful to the subject or likely to impair the subject’s ability to comply with or complete the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum diameter of the lesion;Change in the maximum diameter of the nodule after ablation.;Ultrasound observation of the extent and morphology of necrosis in the ablation zone.;Recurrence or metastasis in the thyroid gland;Fine needle aspiration of the ablation site;Lymph node metastasis;Distant metastasis;Thyroid stimulating hormone;Free Triiodothyronine;Free thyroxine;Human thyroglobulin;Parathyroid hormone;Serum calcium;Serum phosphate;Serum Magnesium; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Countries
China
Contacts
Public ContactWang Yu
Fudan University Shanghai Cancer Center.
Outcome results
None listed