跳至主要内容
临床试验/NCT04580199
NCT04580199Unknown不适用

Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule

Mahmoud Fahd0 个研究点目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
shrinkage of the thyroid nodule

研究概览

简要总结

To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding:

  • Outcome of every type of management
  • Feasibility of minimally invasive technique in management of simple thyroid nodule in Asyut university
  • Complication of every type of management

详细描述

Thyroid nodules are very common in clinical practice; they are discovered by palpation in 3-7% and by ultrasound (US) in about 50% of the general population. The majority of thyroid nodules are benign and asymptomatic. The main management of benign thyroid nodules is observation and follow-up; however, a minority of them (10-15%) increase in size over time and may induce symptoms or cosmetic issues. Surgical excision has been established as a treatment for symptomatic benign thyroid nodules. thyroidectomy for benign thyroid disease continues to remain controversial, as there are many conflicting data published in the literature regarding the risk of hypothyroidism and recurrent laryngeal nerve injury stratified to indications for surgery, extent of thyroid resection and surgical volume .It carries a 2-10% risk of complications and neck scarring .Thyroid surgery is also costly and may not be appropriate for patients who have a high risk of surgical morbidity.Therefore, image-guided nonsurgical procedures such as ethanol ablation (EA) and thermal ablation have been proposed as alternative and less invasive approaches for the management of benign symptomatic thyroid nodules .These so-called thermoablative methods induce local thermodestruction, leading to nodule shrinkage and improvement of local symptoms. Monopolar radiofrequency ablation (RFA) and EA is widely used as a nonsurgical treatment usually for cystic (i.e., pure cyst) or predominantly cystic benign thyroid nodules (i.e., cystic portion > 50%). There is another method called US-guided percutaneous laser ablation (PLA) is a safe and effective therapeutic option as an alternative to surgery for benign symptomatic nodules

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
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

  • complicated thyroid nodule

排除标准

  • less than 18 malignant thyroid nodule

结局指标

主要结局

shrinkage of the thyroid nodule

时间窗: 2 years

decrease in the size of thyroid nodule

次要结局

未报告次要终点

研究者

发起方
Mahmoud Fahd
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Fahd

principle investigator Mahmoud fahd

Assiut University

相似试验