Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm Study

Exclusion Criteria

• •2: History of myocarditis, cardiomyopathy, or malignant arrhythmias. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease (such as an aortic aneurysm at risk of rupture) requiring hospitalization within 12 months prior to the first ablation treatment, or other cardiac damage that may affect the safety evaluation of the study device (e.g., poorly controlled arrhythmias, atrial fibrillation, myocardial ischemia/infarction).
• •3: Patients who are unable to cooperate with treatment or unable to tolerate general anesthesia.
• •4: Presence of distant metastases outside the cervical region.
• •5: Presence of metastatic lymph nodes located in the level VII compartment of the neck.
• •6: Receipt of \^131I therapy within the past 6 months.
• •7: Allergy to ultrasound or CT contrast agents, or inability to undergo contrast-enhanced imaging examinations for other reasons.
• •8: Patients who have undergone neck surgery, local ablation, chemotherapy, or immunotherapy/targeted therapy within the past 3 months.
• •9: In the opinion of the investigator, ablation needles cannot be safely placed.
• •10: Presence of metallic implants (plates, screws, etc.) or non-removable implanted catheters in the neck that may affect electric field distribution.
• •11: Concomitant untreated malignant tumors, or a history of any malignancy within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• •12: Concurrent enrollment in another clinical study.
• •13: Known history of psychiatric disorders, substance abuse, alcoholism, or illicit drug use.
• •14: Major surgery or severe trauma within 30 days prior to the first ablation treatment, or planned major surgery within 30 days after the first ablation treatment (as determined by the investigator).
• •15: History within 6 months prior to the first ablation treatment of esophageal or gastric fundal varices, severe peptic ulcer, unhealed wounds, gastrointestinal perforation, enterocutaneous fistula, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding; acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to the first treatment.
• •16: Any arterial thromboembolic event, venous thromboembolism of grade ≥ 3 according to CTCAE version 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first ablation treatment; or current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite oral antihypertensive therapy.
• •17: Any past or current disease, treatment, or laboratory abnormality that may confound the study results, interfere with the subject's full participation in the study, or make participation not in the subject's best interest.
• •18: Local or systemic diseases not caused by malignant tumors, or tumor-related secondary diseases or symptoms that may lead to high medical risk and/or uncertainty in survival assessment, such as tumor-related leukemoid reaction (white blood cell count \> 20 × 10\^9/L), manifestations of cachexia (e.g., known weight loss of more than 10% within 3 months prior to screening), etc.
• •19: Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
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