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临床试验/NCT06506149
NCT06506149招募中不适用

A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
To measure the remission rate of Graves' disease at 6-months post-procedure

研究概览

简要总结

Graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (ATD), radioiodine (RAI) and surgery. For ATD, it has been the first-line treatment over decades. Despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with RAI or thyroidectomy. However, RAI is not preferable in patients with Graves' ophthalmopathy as it could further worsen eye symptoms. RAI may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. As for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. Due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. With the evolution of thermal ablative strategies, high-intensity focused ultrasound (HIFU) and radiofrequency ablation (RFA) have been reported as feasible treatment options for relapsed Graves' disease. There has also been increasing reports in the use of microwave ablation (MWA) in the treatment of benign thyroid nodules. MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (USG) guidance. The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. As compared to RFA, MWA is not affected by heat sink effect and may require a shorter treatment time. Similar to other thermal ablative approaches, MWA has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.

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

入选标准

  • (a) age older than 18 years,
  • (b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more
  • (c) absence of vocal cord immobility

排除标准

  • (a) patients who prefer or are indicated for surgery,
  • (b) presence of head and/or neck disease preventing hyperextension of the neck,
  • (c) history of thyroid cancer or other malignant tumours in the neck region,
  • (d) history of neck irradiation,
  • (e) severe Graves' ophthalmopathy,
  • (f) large compressive goitre,
  • (g) pregnancy or lactation, and
  • (h) any contraindication to intravenous sedation.

结局指标

主要结局

To measure the remission rate of Graves' disease at 6-months post-procedure

时间窗: 6 months

To measure the remission rate of Graves' disease at 6-months post-procedure

次要结局

  • Change of quality of life by SF12 ver 2(6 months)
  • To measure the percentage of volume change(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Man Him Matrix Fung

Clinical Assistant Professor

The University of Hong Kong

研究点 (2)

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