Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage change in nodule volume
研究概览
简要总结
Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.
The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.
Primary objective:
- To evaluate the safety, efficacy and oncological outcomes of the procedure.
Secondary objective:
- To determine the patient functional outcomes in comparison to the observational control.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
- •Solitary thyroid nodule <20mm in maximal dimension.
- •No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
- •There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.
排除标准
- •Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
- •Clinically apparent multicentricity
- •Lesions larger than 20 mm in maximum diameter.
- •Recurrent laryngeal nerve palsy.
- •Extension of nodule to posterior thyroid capsule.
- •Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
- •Pregnancy.
- •Pacemaker.
- •Previous RFA.
结局指标
主要结局
Percentage change in nodule volume
时间窗: Baseline and 12 months
This will assess the percentage change in nodule volume (cubic millimeters).
次要结局
- Percentage change in nodule volume(Baseline and 24 months)
- Change in voice related quality of life as assessed by the VHI-10(Baseline and 24 months)
- Number of complications(12 months)
- Change in eating assessment score as assessed by the EAT-10(Baseline and 24 months)
- Change in overall quality of life assessed by the PROMIS score(Baseline and 24 months)
- Scar cosmesis score(24 months)