Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma (RFAforPTMC)
2022年10月25日 更新者：Ji-hoon Kim、Seoul National University Hospital
Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.
研究概览
详细说明
For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance.
Before RFA, local anesthesia will be performed.
RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used.
With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used.
After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ji-hoon Kim, MD,Ph.D
- 电话号码：+82-2-2072-3280
- 邮箱：jihnkim@gmail.com
学习地点
-
-
-
Seoul、大韩民国、03080
- 招聘中
- Seoul National University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- who agrees to the consent form
- aged from 19 to 60 years old
- who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy
- whose thyroid cancer is 1 cm or smaller than 1 cm length
- who does not have lymph node or distant metastasis
- whose thyroid cancer does not have extrathyroidal extension
- in whom it seems technically possible to completely ablate thyroid cancer using RF
Exclusion Criteria:
- who cannot routinely followed up according to the study schedule
- who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy.
- who has hyperthyroidism that requires treatment
- who has bleeding tendency
- multifocal papillary thyroid microcarcinoma
- who is pregnant
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：RFA for PTMC
Group who will undergo RFA after diagnosis of PTC
|
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of tumor size
大体时间：baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
Maximal dimension (mm) of ablation zone on Ultrasonography
|
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Development of Metastasis
大体时间：baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
Cervical Lymph node metastasis on Ultrasonography or other distant metastasis
|
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
|
Change of Quality of Life
大体时间：baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients
|
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
|
Incidence of potential side effects from RFA
大体时间：baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
rate of patients who underwent potential side effects from RFA
|
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ji-hoon Kim, MD,Ph.D、Seoul National University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年4月16日
初级完成 (预期的)
2023年7月31日
研究完成 (预期的)
2023年12月31日
研究注册日期
首次提交
2018年1月22日
首先提交符合 QC 标准的
2018年2月7日
首次发布 (实际的)
2018年2月14日
研究记录更新
最后更新发布 (实际的)
2022年10月26日
上次提交的符合 QC 标准的更新
2022年10月25日
最后验证
2022年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.