Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Disease-free
研究概览
简要总结
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.
详细描述
We hypothesize that percutaneous ethanol ablation (PEA) for primary papillary thyroid microcarcinoma (PTMC) has equivalent oncologic outcomes to current treatment options including observation, thyroid lobectomy and total thyroidectomy. In addition, we hypothesize that it will yield superior long-term quality of life, including measures of pain, voice, and cosmesis than standard surgical therapy (total thyroidectomy). If our hypotheses are correct, the findings of this study have the potential to fundamentally change clinical management of this group of patients.
This study was changed from its initial design: a 2 arm study comparing PEA to surgery (Amended April 30, 2015). The change in design was made based on several discussions within Yale Endocrine Surgery, with patients diagnosed with PTMC, and knowledge of other institutions performing PEA for PTMC as standard of care.
The study team had been contacted by numerous potential subjects interested in PEA who were unwilling to be randomized to surgery. Because patients interested in PEA appeared to be firmly against the idea of thyroidectomy, we believed that we would be unable to enroll sufficient patients to this study as the protocol originally stood.
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
- 否
入选标准
- •Age 18 years and older
- •Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound
排除标准
- •Patient refusal to participate
- •History of prior thyroid or parathyroid surgery
- •Previous recurrent laryngeal nerve injury
- •Inability to make decisions or comply with follow up
- •Co-existing indication for thyroidectomy
- •Aggressive cytological or molecular features
- •Multifocal papillary thyroid carcinoma
- •Pregnant or breast-feeding
- •Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea)
- •Documented or suspected distant metastasis
- •History of radiation to neck or face
- •Family history of thyroid cancer
研究组 & 干预措施
percutaneous ethanol ablation
The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.
干预措施: percutaneous ethanol ablation (Drug)
结局指标
主要结局
Disease-free
时间窗: 5 years
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Overall Survival
时间窗: 5 years
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
次要结局
- Quality of Life(5 years)
- Patient Satisfaction(5 years)