Actively Recruiting

Age: 18Years +
All Genders
ID05189314

Clinical Outcomes and Quality of Life After Surgery and Radiofrequency Ablation of Benign Thyroid Nodules

Led by Columbia University · Updated on 2025-05-28

100

Participants Needed

1

Research Sites

413 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Benign multinodular goiter (MNG) is an enlarged thyroid gland with multiple nodules, often due to iodine deficiency, and is the most common endocrine disorder worldwide. Significant nodule growth can cause symptoms like difficulty swallowing, breathing problems, or pressure on neck vessels. While surgery has been the usual treatment to relieve these symptoms and manage hormone levels, it carries some risks such as nerve injury and hypothyroidism. Recently, thermoablative methods like monopolar radiofrequency ablation (RFA) have emerged as alternative treatments to shrink nodules and improve symptoms. This study compares clinical outcomes and quality of life in patients treated for symptomatic benign multinodular goiter using either surgical removal of thyroid nodules (thyroidectomy) or radiofrequency ablation. RFA uses an FDA-cleared device to heat and destroy nodule tissue under ultrasound guidance. Both treatments aim to reduce nodule size and symptoms. The study collects data from patients before and after their treatments to evaluate effects over time. Participants provide medical information from before and after treatment, including assessments at 6 and 12 months to measure changes in nodule volume, thyroid stimulating hormone (TSH) levels, and quality of life using the ThyPRO 39 survey. Researchers monitor these outcomes to understand how each treatment impacts thyroid nodules and patient well-being over time. The study focuses on adults aged 18 and older with benign thyroid nodules.

CONDITIONS

Official Title

RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients �3e/=18 years old with benign thyroid nodules
Not Eligible

You will not qualify if you...

  • Cardiac arrhythmia
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Columbia University

New York, New York, United States, 10032

Actively Recruiting

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Research Team

J

Jennifer H Kuo, MD MS

V

Vilma Rosario

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Unilateral benign multinodular versus solitary goiter: Long-term contralateral reoperation rates after lobectomy.

Beatriz de Rienzo-Madero, John P Sabra, Elise Gand...

https://pubmed.ncbi.nlm.nih.gov/30415868

Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations.

Dong Gyu Na, Jeong Hyun Lee, So Lyung Jung...

https://pubmed.ncbi.nlm.nih.gov/22438678

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE.

Hossein Gharib, Enrico Papini, Jeffrey R Garber...

https://pubmed.ncbi.nlm.nih.gov/27167915

Benign predominantly solid thyroid nodules: prospective study of efficacy of sonographically guided radiofrequency ablation versus control condition.

Jung Hwan Baek, Yoon Suk Kim, Ducky Lee...

https://pubmed.ncbi.nlm.nih.gov/20308523