Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study
Benign Thyroid Nodule
About this trial
This is an interventional treatment trial for Benign Thyroid Nodule
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Patients with solitary or dominant nodules with two consecutive fine needle aspiration biopsy (FNAb)-proven benign in the last 12 months Thyroid nodules should be solid or almost solid (less than 40% of liquid component) with volume between 5 and 65 cc; Patients considered high surgical risk candidates or patients are eligible to surgery who are informed about the ablation therapy and prefers it instead surgery; Calcitonin, thyroglobulin or TSH serum levels in the normal range values No thyroid autoimmune signs on ultrasound or by autoantibody levels above 100% of the standard levels Exclusion Criteria: Age under 18 years Extensive goiter Predominantly cystic nodule with small solid remnant (less than 10%) Hyperfunctioning nodules (confirmed by scintigraphy) Nodule volume > 65 cc TSH levels above the normal range Auto-immune treatment / thyroiditis Uncorrectable coagulopathy / impossibility to interrupt anticoagulants; Malignant or suspected malignant cytologic specimens; Pregnancy or breast-feeding; Anaplastic or poor-differentiated thyroid carcinoma; Partial thyroidectomy Asymptomatic patients
Sites / Locations
- University of Sao Paulo General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cryoablation
Radiofrequency
Device: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
Single session with an RF device; an antenna will be used for the treatments; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;