Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Volume Reduction Rate (VRR)
研究概览
简要总结
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:
- Does RFA procedure reduce the size of thyroid nodules (measured by volume reduction rate - VRR)?
- What medical problems or complications do participants experience after undergoing RFA?
- How does RFA affect thyroid hormone levels (TSH, FT4)?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Volume Reduction Rate (VRR)
时间窗: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = \[(Initial Volume - Follow-up Volume) / Initial Volume\] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
volume reduction rate (VRR) at 1, 6, and 12 months post-procedure.
时间窗: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = \[(Initial Volume - Follow-up Volume) / Initial Volume\] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
Volume Reduction Rate (VRR)
时间窗: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = \[(Initial Volume - Follow-up Volume) / Initial Volume\] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
volume reduction rate (VRR) at 1, 6, and 12 months post-procedure.
时间窗: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = \[(Initial Volume - Follow-up Volume) / Initial Volume\] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
次要结局
- Assess the safety of single-session RFA(1 month, 6 months, 12 months)
- Assess the safety of single-session RFA(1 month, 6 months, 12 months)
研究者
Le Van Chi
professor
Hue University of Medicine and Pharmacy