Thyroid Tumor
Conditions
Interventions
Experimental Group:Irreversible Electroporation ablation therapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, regardless of sex; 2. Thyroid nodule indicated by ultrasound, with no more than one nodule requiring treatment, and meeting either of the following conditions: (1) Papillary thyroid microcarcinoma confirmed by FNA or CNB, with tumor diameter <=1 cm; (2) Benign nodule confirmed by FNA, with nodule diameter <= 3 cm; 3. No extrathyroidal invasion of the lesion; 4. No imaging or clinical evidence of distant metastasis or lymph node metastasis; 5. The patient is assessed as unable to tolerate surgical treatment due to their own condition, or subjectively refuses surgical treatment after being fully informed; 6. Voluntarily participates in this study and signs the informed consent form, and is able to comply with follow-up visits and examinations required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Family history of thyroid cancer, or history of cervical radiation exposure during adolescence or childhood; 2. Presence of coarse calcification within the lesion; 3. Patients with implanted devices such as a cardiac pacemaker or metal stent; 4. Patients with a history of epilepsy or myocardial infarction within the past six months; severe cardiac or pulmonary disease; severe hepatic or renal dysfunction/failure, defined as total bilirubin >= 2 times the upper limit of normal, AST or ALT >= 2 times the upper limit of normal, creatinine >= 1.5 times the upper limit of normal; hemoglobin < 70 g/L or platelet count < 80×10?/L; 5. Coagulation disorder with severe bleeding tendency, or use of anticoagulant drugs within one week; 6. Impaired consciousness or impaired neck extension resulting in inability to tolerate ablation treatment; 7. Known allergy to contrast agents; 8. Dysfunction of the contralateral vocal cord; 9. Concurrent other malignant tumors, including other thyroid malignancies, or hyperthyroidism; 10. Acute infection or acute phase of chronic infection; 11. Women who are pregnant or breastfeeding, or who plan to become pregnant within six months; 12. Patients with mental abnormalities or a history of psychiatric disease; 13. Patients diagnosed with hepatitis C, HIV, or syphilis; 14. Participation in another interventional clinical trial within one month before the start of this trial; 15. Other patients considered by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ablation Success Rate (for PTMC Patients);6 month postoperative target lesion volume reduction rate (for patients with benign nodules); | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative Biopsy Rate at 6 Months Post-Surgery (for PTMC Patients);Target Lesion Disappearance Rate;Target Lesion Volume Reduction Rate;Device Performance Evaluation;Local Tumor Recurrence Rate;Thyroid Function Parameters; | — |
Countries
China
Contacts
Public ContactDong Xu
Zhejiang Cancer Hospital
Outcome results
None listed