Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study

Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study

Title:

Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study

Purpose:

The goal of this clinical trial is to learn if single-session radiofrequency ablation (RFA) can effectively reduce the volume of benign thyroid nodules in adults. It will also evaluate the safety of the RFA procedure.

The main questions it aims to answer are:

1. Does RFA procedure reduce the size of thyroid nodules (measured by volume reduction rate - VRR)?
2. What medical problems or complications do participants experience after undergoing RFA?
3. How does RFA affect thyroid hormone levels (TSH, FT4)?
4. Is RFA equally effective in purely cystic nodules, solid nodules, and predominantly cystic nodules?

Comparator:

This is a single-arm study, so there is no placebo or comparison treatment group. All participants will undergo RFA, and the results will be assessed over time.

Participants will:

• Undergo one session of RFA for benign thyroid nodules.
• Be followed up with clinical visits and ultrasound assessments at 1, 6, and 12 months.
• Have thyroid hormone levels tested and nodule size measured by ultrasound at each follow-up.
• Be monitored for any side effects or complications such as voice changes, pain, or bleeding.

Inclusion Criteria:

• Patients with thyroid nodules, confirmed by ultrasound.
• Presence of compressive symptoms (e.g., dysphagia, neck pressure) or cosmetic concerns.
• Documented thyroid function tests (serum free thyroxine [FT4] and thyrotropin [TSH]).
• Cytology-confirmed benign thyroid nodules via one or two ultrasound-guided fine-needle aspiration (FNA) procedures.
• Refusal of surgical treatment.
• Ability to complete follow-up assessments at 1, 6, and 12 months post-procedure.

Exclusion Criteria:

• Malignant or indeterminate cytology on FNA.
• Contraindications to RFA (e.g., severe coagulopathy, pregnancy).
• Uncontrolled thyroid dysfunction (e.g., hyperthyroidism or hypothyroidism).
• Inability to provide informed consent or comply with follow-up