跳至主要内容
临床试验/NCT05798936
NCT05798936尚未招募4 期

Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous Ultrasound Guided Treatment of Benign Thyroid Cyst

Assiut University0 个研究点目标入组 30 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
30
主要终点
Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol)

研究概览

简要总结

This study aims to compare the efficacy and safety of ultrasound-guided percutaneous ethanol injection and percutaneous polidocanol injection for the treatment of benign cystic and predominantly cystic thyroid nodules.

详细描述

Thyroid nodules are characterized by excessive structural growth, functional transformation, and/or cystic degeneration of one or several areas within the gland. According to various studies, 15-30% of thyroid nodules are cystic or predominantly cystic. Around 5% of patients with thyroid nodules may experience compressive symptoms or cosmetic concerns, and treatment may be required in these cases.

Simple aspiration is generally the initial management for the purpose of diagnosis and cyst volume reduction. However, the recurrence rate has been reported to be high (40% to 59%), depending on the number of aspirations and extent of fluid evacuation. After simple fine-needle aspiration, most cystic lesions (around 80%) refill and enlarge over time.

Surgery is a long-established therapeutic option for benign thyroid nodules. However, the cost of thyroid surgery, risk of temporary or permanent complications, and impact on quality of life remain relevant concerns.

Ultrasound-guided percutaneous ethanol injection (PEI) The mechanism of ethanol sclerotherapy is that ethanol induces cellular dehydration and protein denaturation, which are followed by coagulation necrosis, reactive fibrosis, and small-vessel thrombosis.

As regard (PEI)Pain is the most common side effect, other mild side effects or complications occurred in small numbers of patients like: Facial flushing, Mild dizziness, Intracystic haemorrhage, drunken sense, Perithyroidal leakage. There are other side effects, including transient vocal cord palsy, respiratory distress requiring emergency surgical treatment, and venous thrombosis, in sporadic cases.

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
10 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single cystic or predominantly cystic nodules.
  • Pressure symptoms or cosmetic problems.
  • No malignant or indeterminate cytologic results after ultrasound-guided fine-needle aspiration.
  • Normal serum thyroid hormone levels

排除标准

  • Association of a nodules showing malignant features on us examinations.
  • Malignant or indeterminate cytologic results after ultrasound-guided fine-needle aspiration.
  • Abnormal serum thyroid hormone levels

研究组 & 干预措施

Polidocanol group

Experimental

Polidocanol is injected in the thyroid cyst under ultrasound guidance.

干预措施: Polidocanol (Drug)

Alcohol group

Experimental

Alcohol is injected in the thyroid cyst under ultrasound guidance.

干预措施: Alcohol (Drug)

结局指标

主要结局

Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol)

时间窗: 3 months

Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection

次要结局

未报告次要终点

研究者

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

Amna Ahmed Ali Ahmed

Doctor

Assiut University

相似试验