A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Quality of life
研究概览
简要总结
There have been previous reports of using High-intensity focused ultrasound (HIFU) as a feasible thermal ablative treatment for relapsed Graves' disease. In recent years, radiofrequency ablation (RFA) has become another promising alternative for thermal ablation of benign thyroid nodules. RFA has the advantage of avoiding a surgical scar, organ preservation and being an ambulatory procedure. It utilizes a small caliber radiofrequency electrode, which is inserted into the thyroid gland percutaneously. The active tip of the RF electrode would induce frictional heat in the surrounding tissue, causing a thermal ablative effect. The direct application of energy of RFA to tissue is different from that in HIFU, in which energy is transmitted through the skin of the participants from the transducer.
Studies of follow-up after RFA of Graves' disease have not been published. Given the previous successful experience with HIFU, the investigators would like to explore the feasibility, safety and efficacy of RFA as an alternative thermal ablation option for relapsed Graves' disease. Thus, the purpose of this prospective study is to assess the efficacy and safety of US-guided RFA for the treatment of relapsed Graves' disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) age older than 18 years,
- •(b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more and
- •(c) absence of vocal cord immobility.
排除标准
- •(a) patients who prefer or indicated for surgery,
- •(b) head and/or neck disease preventing hyperextension of the neck,
- •(c) history of thyroid cancer or other malignant tumors in the neck region,
- •(d) history of neck irradiation,
- •(e) moderate to severe Graves' ophthalmopatty,
- •(f) large compressive goiter
- •(g) pregnancy or lactation, and
- •(h) any contraindication related to intravenous moderate sedation.
结局指标
主要结局
Change in Quality of life
时间窗: 24 months, 36 months
To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months
Mid term remission rate after a single course of RFA
时间窗: 24 months and 36 months
Graves' disease remission after a single course of RFA
Complication rates
时间窗: 1 month
To measure the complication rates after RFA
Short term disease remission rate after a single course of RFA
时间窗: 12 months
Graves' disease remission rate after a single course of RFA
次要结局
未报告次要终点
研究者
Dr. Lang Hung Hin, Brian
Clinical Professor
The University of Hong Kong