Ultrasound-guided Radiofrequency Ablation versus radioactive iodine as Treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules

In about 5-10% of patients presenting with hyperthyroidism the elevated thyroid
hormone levels are produced by a hyperactive
thyroid node (HTN) . The current standard of care for hyperthyroidism caused by
a solitary HTN is treatment with radioactive iodine
(RAI). It is very effective in controlling hyperthyroidism but is associated
with a high risk of irreversible hypothyroidism, increasing
from 10 - 35% at one year to up to 60% after 20 years. These patients will need
treatment with thyroid hormone for life. This
implies that the long-term cure rate of RAI, defined as the percentage of
patients with a persistent normalization of thyroid function,
is low. Recently, radiofrequency ablation (RFA) has been introduced as a new
treatment option. RFA leads to a normalization of
thyroid function in 60 - 75% of patients within one year, and is associated
with a 3% risk of permanent hypothyroidism. It is
currently not known which treatment is most effective in establishing the
highest long-term cure rates. We hypothesize that RFA
treatment is associated with a lower rate of irreversible hypothyroidism, and
therefore a higher long-term cure rate.

This study has been transitioned to CTIS with ID 2024-515602-34-01 check the CTIS register for the current data.

To assess which treatment leads to the best patient outcome on the short term
(1 year) and the long term (5 years)

Multicentre, randomized controlled trial, nested within a prospective cohort
study with a 5-year follow-up

Patients agreeing to participate in randomization will be randomized to receive
treatment with either RAI (group 1), or RFA (group
2). Patients declining randomization but agreeing to follow-up will receive the
local standard treatment with either RAI, Surgery or
anti-thyroid drugs (group 3).

Patients randomized for this study receive a treatment and follow-up scheme
closely resembling clinical practice. In addition, patients will be asked to
fill out questionnaires on (thyroid related) quality of life, medical
consumption and patient experience, at baseline and 3 times in the first year
after treatment. Patients randomized to the RFA arm will undergo RFA according
to current practice guidelines as performed for non-functioning thyroid nodules
which is associated with a low procedure related risk profile. Procedure
related minor events occur in 5% of patients and include local haemorrhage and
swelling. Transient worsening of hyperthyroidism due to post RFA thyroiditis
occurs in less than 5% of patients. A severe adverse event, transient laryngeal
nerve damage, has been observed in 0.5% of patients and irreversible
hypothyroidism is expected to occur in less then 3% of patients.