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

Hue University of Medicine and Pharmacy

Status: Active, not recruiting

Conditions: Benign Thyroid Nodules

Treatments: Procedure: Radiofrequency ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT07115576

H2023/050

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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106 participants in 2 patient groups

primary end-point

Experimental group

Description:

To evaluate the efficacy of RFA procedure in reducing the volume of benign cystic thyroid nodules, measured by the volume reduction rate (VRR) at 1, 6, and 12 months post-procedure.

Treatment:

Procedure: Radiofrequency ablation alone

Secondary end-point

Experimental group

Description:

• To assess the safety of RFA procedure, including the incidence of major and minor complications.

Treatment:

Procedure: Radiofrequency ablation alone