Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Reduction of volume of the cyst about 96.9%
研究概览
简要总结
Use of ethanol injection in treatment of cystic thyroid nodule
详细描述
Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection.
Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.
Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female patient with cystic thyroid nodule
- •Presence of pressure symptoms or cosmetic problems
- •Benign lesions confirmed by histopathological examination by FNAC.
- •Serum levels of thyroid hormone thyrotropin, within normal limits.
排除标准
- •Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
- •solid thyroid nodule
- •mixed thyroid nodule(cystic with solid component)
研究组 & 干预措施
injection of ethanol
use of ethanol injection in the treatment of cystic thyroid nodule
干预措施: ethanol injection (Drug)
结局指标
主要结局
Reduction of volume of the cyst about 96.9%
时间窗: Reduction of volume of the cyst about 96.9% within 6 month
Reduction of volume of the cyst about 96.9%
次要结局
- symptomatic improvement(3 month)
研究者
hassan harby mohamed
general surgery
Assiut University