RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study
- Conditions
- Thyroid Nodules
- Interventions
- Procedure: ThyroidectomyDevice: Radiofrequency Ablation
- Registration Number
- NCT05189314
- Lead Sponsor
- Columbia University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Adult patients >/=18 years old with benign thyroid nodules
- cardiac arrhythmia
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Thyroidectomy Thyroidectomy Patients with benign thyroid nodules who undergo surgical resection RFA Radiofrequency Ablation Patients with benign thyroid nodules who undergo radiofrequency ablation
- Primary Outcome Measures
Name Time Method ThyPRO 39 Survey Score 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) 6 months and 12 months Change in serum TSH
Percent Volume Change of Nodules 6 months and 12 months Percent Volume Change of Nodules: ((Volume (baseline) - Volume (\*m\*))/Volume(baseline))\*100
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Columbia University
🇺🇸New York, New York, United States