Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- The proportion of patients with major complications occurring within one month after the date of intervention
研究概览
简要总结
This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)
详细描述
Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function.
This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients > 18years
- •Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
- •Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- •Patients must be accessible for follow-up
排除标准
- •Tumors > 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders
- •Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
结局指标
主要结局
The proportion of patients with major complications occurring within one month after the date of intervention
时间窗: 1 month
Complications will be reported according to modified Society of Interventional Radiology (SIR) classification
次要结局
- Percentage of patients died at 10 years(10 years)
- Percentage of patients with distant metastasis at 10 years(10 years)
- Percentage of patients with local recurrence at 10 years(10 years)