Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) Versus Thionamides (Anti-Thyroid Drugs) in Patients With Moderate-to-Severe Graves' Ophthalmopathy - a 1-year Follow-up
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Muscle index (MI) from ultrasound measurements
研究概览
简要总结
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
详细描述
Introduction
Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective
To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Observer blinded analysis
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GD and GO onset < 12 months
- •no previous GD treatment other than antithyroid drugs (ATD)
- •first relapse after decrease of antithyroid medication within 4-6 months
- •GO treatment with glucocorticoids based on the Kahaly scheme
- •patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
- •clinically active inflammation according to CAScore (>3/7)
- •informed consent
排除标准
- •GD and GO onset > 12 months
- •more than one relapse of GO longer than 6 months from diagnosis
- •previous GD treatment by RAI or surgery
- •SNI greater than 7.0
- •urgent orbital decompression surgery
- •loss of vision
- •loss of visual field
- •loss of color vision
- •patients not receiving glucocorticoids for GO
- •cytological findings of postsurgical histopathological results suspicious for malignancy
- •pregnancy or breast-feeding
- •contraindication to GC
- •halt of GC therapy
- •Patients with diabetes mellitus
- •age below 18 years
- •no informed consent
研究组 & 干预措施
Thyroidectomy
Total thyroidectomy
干预措施: Antithyroid Drug (Drug)
Antithyroid drug
Thiamazol, Propylthiouracil
干预措施: Total thyroidectomy (Procedure)
结局指标
主要结局
Muscle index (MI) from ultrasound measurements
时间窗: 12 months
Muscle index (MI) from ultrasound measurements
Thyroid antibodies
时间窗: 12 months
Thyroid antibodies
次要结局
- CAScore/NOSPECS score(12 months)
- Quality of life score(12 months)
- Superonasal index measurements via ultrasound(12 months)
研究者
Philipp Riss
Professor
Medical University of Vienna