Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction
Conditions
Brief summary
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Interventions
DEVICERadiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
I-131 according to standardized doses-calculation.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
University of Twente
Amsterdam UMC
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre 1:1 randomized clinical trial where patients are allocated to either radiofrequency ablation (RFA) or radioactive iodine (RAI) (I-131). Patients who are not suitable for randomization (e.g. no informed consent or contra-indication for RFA) are asked for consent to participate in a prospective cohort where participants are asked to fill out questionaires and data is collected.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics: * Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels * Anti-TSH antibody negative * Solitary HTN confirmed by a diagnostic I-123 scintigraphy, corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration \< 75%, nodule size \<50 mm. * Treatment with RAI indicated, and eligible for RFA treatment * Signed informed consent Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group.
Exclusion criteria
* Multifocal HTN * HTN \> 50 mm * Presence of a medical device susceptible to disturbances caused by RFA generated currents * Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local anesthesia * Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility * Uncorrectable haemorrhagic diathesis * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothyroidism | 1 year post-intervention | Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate | 1 year post-intervention | Medication-free normalization of TSH, FT4 and FT3 levels |
| Thyroid nodule volume | Baseline, 6 and 12 months post-intervention | Volume of thyroid nodule assessed by ultrasound |
| Treatment related adverse events | 6 weeks and 3, 6 and 12 months post-intervention | Number of adverse and serious adverse events |
| Thyroid related quality of life | Baseline, 6 and 12 months after intervention | Thyroid related quality of life assessed by ThyPro questionnaire |
| Cost-effectiveness | Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention | Determined as the incremental costs in Euros per quality adjusted life year (QALY) |
| Course of thyroid function | Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years. | Assessed by TSH, FT4 and FT3 an medication use |
| Short-term patient satisfaction | 1 week and 1 year post-intervention | 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'). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of hospital resources | 1 year post-intervention | According to medical records |
| Medical consumption | 1 year post-intervention | iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire) |
| Use of healthcare resources | 1 year post-intervention | iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire) |
| Cumulative cost | 1 year post-intervention | Based on Rijnstate price estimates |
| Fractional nodal uptake | 1 year post-intervention | Assessed by I-123 or I-131 scintigraphy |
| Treatment related auto-immunity | Baseline and 1 year post-intervention | Assessed by thyroid antibodies |
| Health outcomes and quality of life | Baseline, 6 and 12 months after intervention | Assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire. ( questions in 5 dimensions with 3 response levels, a higher score representing a worse outcome) |
Countries
Netherlands
Outcome results
None listed