RABITO-study

Ultrasound-guided Radiofrequency Ablation versus radioactive Iodine as treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules.

RABITO-study
Lopend onderzoek

Background

The treatment of hyperthyroidism caused by an autonomous thyroid nodule currently involves the use of radioactive I-131. A common complication of this therapy is the occurrence of hypothyroidism with an incidence of 10 - 35% one year after treatment and 60% 20 years after the treatment. These patients require lifelong thyroid hormone supplements. In recent years, radiofrequency ablation (RFA) has been introduced as a treatment option for patients with physical symptoms resulting from an inactive benign thyroid nodule. It is an effective treatment for volume reduction (70 - 80% after one year). The therapy is safe; the complication of vocal cord paresis occurs in 0.05% of the cases treated. RFA was also used, to a more limited extent, to treat patients with hyperthyroidism caused by thyroid hormone-producing nodules. Normalization of thyroid function is achieved in approximately 70% of cases after one year, and the incidence of hypothyroidism is probably < 1%.

Purpose
The purpose of this study is to be able to compare the standard treatment, I-131, directly with the new treatment, RFA. The primary outcome measure is hypothyroidism. Furthermore, the recovery of the thyroid function, volume reduction of the treated nodule, quality of life (whether related to the thyroid or not), patient preferences, and cost-effectiveness will be assessed.

Study design
Randomized multicenter study in which patients are allocated 1:1 to RFA and I-131. Regular check-ups in line with current practice and online questionnaires for patients for one year. After that year, the patients will be monitored for a total of five years.

Inclusion criteria
  • Age > 18 years
  • Hyperthyroidism caused by single autonomously functioning thyroid nodule, demonstrated by:
    • Suppressed TSH with or without elevated FT4/FT3
    • Negative anti-TSH
    • Ultrasound showed single nodule or multinodular goiter
    • Scintigraphy showed one autonomous nodule
  • Eligible for I-131 treatment
  • RFA treatment appropriate
  • Informed consent
Exclusion criteria
  • Multifocal autonomy (toxic multinodular goiter)
  • Nodule > 5cm
  • Nodule > 75% cystic degeneration
  • Medical device sensitive to RFA currents
  • Dysphagia or other reason why I-131 may not be taken
  • Untreatable hemorrhagic diathesis
  • Pregnant or breastfeeding
Additional information
www.rijnstate.nl/schildklieronderzoek

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