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临床试验/NCT05189314
NCT05189314招募中不适用

Clinical Outcomes and Quality of Life Measures After Surgical Resection and Radiofrequency Ablation of Benign Thyroid Nodules

Columbia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
ThyPRO 39 Survey Score

研究概览

简要总结

The purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (MNG) patients. This is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

详细描述

Benign multinodular goiter (MNG) refers to an enlarged thyroid gland with nodules within it, frequently owing to iodine deficiency. It is the most common endocrine disorder worldwide.

Significant growths of nodules can cause symptomatic compressive symptoms such as dysphagia, dyspnea, or vascular compression of the neck vessels. On occasion, these nodules can develop autonomy and secrete excess thyroid hormone (toxic multinodular goiter). Surgical resection has been the preferred treatment option for symptomatic multinodular goiters and addresses both compressive symptoms as well as hyperthyroidism, but is associated with small, but not negligible risk of nerve injury, hypoparathyroidism, and may confer a risk of hypothyroidism and dependence on thyroid hormone supplementation.

Thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for MNG. Monopolar radiofrequency ablation (RFA) is presently the best documented thermoablative technique. Although RFA of thyroid nodules specifically, is still considered investigational in the United States, RFA of thyroid nodules has been used by several centers globally (mainly in South Korea, Italy, China, and Austria) since 2006 with excellent clinical outcomes. In addition, RFA of other solid tumors is a commonly performed procedure in the United states and all RFA devices, including the device that we will use for the clinical care of these patients, are cleared by the FDA (New devices/technology to the market are approved, but devices that have a predicate device/technology that are already on the market only need to be cleared). In response to its increasing popularity, the Korean Society of Thyroid Radiology commissioned a Task Force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012, and these recommendations were recently revised in 2017 and the American Association of Clinical Endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Adult patients >/=18 years old with benign thyroid nodules

排除标准

  • cardiac arrhythmia
  • pregnancy

结局指标

主要结局

ThyPRO 39 Survey Score

时间窗: 12 months

The Thypro 39 is a survey assessing quality of life in patients with thyroid disease. Scores range from 0-100 with a higher score indicating a worse outcome.

Change in Thyroid Stimulating Hormone (TSH)

时间窗: 6 months and 12 months

Change in serum TSH

Percent Volume Change of Nodules

时间窗: 6 months and 12 months

Percent Volume Change of Nodules: ((Volume (baseline) - Volume (\*m\*))/Volume(baseline))\*100

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

Jennifer Kuo

Associate Professor

Columbia University

研究点 (1)

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