The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
I-131 according to standardized doses-calculation.
I-131 according to local standard.
Ziekenhuis Groep Twente
Almelo, Gelderland, Netherlands
Gelre Hospitals
Apeldoorn, Gelderland, Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Hypothyroidism
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
Time frame: 1 year post-intervention
Cure rate
Medication-free normalization of TSH, FT4 and FT3 levels
Time frame: 1 year post-intervention
Thyroid nodule volume
Volume of thyroid nodule assessed by ultrasound
Time frame: Baseline, 6 and 12 months post-intervention
Treatment related adverse events
Number of adverse and serious adverse events
Time frame: 6 weeks and 3, 6 and 12 months post-intervention
Thyroid related quality of life
Thyroid related quality of life assessed by ThyPro questionnaire
Time frame: Baseline, 6 and 12 months after intervention
Cost-effectiveness
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
Time frame: Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention
Course of thyroid function
Assessed by TSH, FT4 and FT3 an medication use
Time frame: Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.
Short-term patient satisfaction
Assessed by interviews, satisfaction questionnaire and pain scoring by visual analog scale (VAS, a scale ranging from 0-10 represented as a line with 0 on the left end indicating 'no pain' and 10 on the right end, indicating 'the worst pain').
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Laurentius Hospital
Roermond, Limburg, Netherlands
Amphia Hospital
Breda, North Brabant, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Elkerliek Hospital
Helmond, North Brabant, Netherlands
Amsterdam UMC, location VUMC
Amsterdam, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
...and 4 more locations
Time frame: 1 week and 1 year post-intervention