Thyroid nodules can create issues for individuals such as affecting the level of their thyroid hormones, causing an unwanted physical appearance, or pressing on other important structures in the neck (for example, trachea and esophagus). In the past, surgery was typically used to treat thyroid nodules causing the above issues, either taking out some or all of the thyroid. More recently, new techniques that do not require surgery have been developed to treat these issues. This study is investigating the use of one of these newer techniques, called radiofrequency ablation in Latinx patients with non-cancerous symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery (like bleeding, infection, scars) and can be done in a clinic setting. The theory is that this procedure will be a safe and effective alternative to surgery for non-cancerous thyroid nodules that are causing symptoms in Latinx patients, which is a population in which this treatment has not yet been studied. Patients who decide to enroll in the study will be required to fill out questionnaires, have blood tests, have ultrasounds of the thyroid, and undergo the radiofrequency ablation minimally-invasive treatment instead of surgery. Patients will be evaluated at 1 month, 3 months, 6 months, 12 months, and 18 months after the procedure to assess for effectiveness of the procedure and any side effects.
Most evidence supporting RFA of thyroid nodules comes from international cohorts. In a recent meta-analysis, RFA accomplished volume reduction ranging from 68 to 87% in over 1100 treated nodules. This reduction was sustained for up to 5 years. In terms of its safety, a recent systematic review of 2700 nodules showed only 41 major complications and 48 minor complications from RFA. Of note, most complications were transient, only 4 patients developed permanent voice changes, while 1 required rescue lobectomy after a nodule ruptured. Published data in the United States also showed RFA to be an effective and safe strategy. However, of the 47 studied patients, none were LatinX. Furthermore, lack of coverage by insurance companies means this procedure is typically only available as an out-of-pocket expense and is therefore out of reach for underserved patients. Data to establish the safety/feasibility of this novel intervention is needed for the LatinX population.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.