Clinical trial NCT05189314: RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study
Official title: Clinical Outcomes and Quality of Life Measures After Surgical Resection and Radiofrequency Ablation of Benign Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Nodules
Keywords: Radiofrequency Ablation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>/=18 years) with benign, non-functional benign thyroid nodules

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* cardiac arrhythmia
* pregnancy

Primary outcomes:
measure: Percent Volume Change of Nodules
timeFrame: 6 months and 12 months
measure: Change in Thyroid Stimulating Hormone (TSH)
timeFrame: 6 months and 12 months
measure: ThyPRO 39 Survey Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Jennifer H Kuo, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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