Radiofrequency Ablation Clinical Trial
— RABITOOfficial title:
Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Status | Recruiting |
Enrollment | 232 |
Est. completion date | December 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Ziekenhuis Groep Twente | Almelo | Gelderland |
Netherlands | Amsterdam UMC, location VUMC | Amsterdam | Noord-Holland |
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Netherlands | Amphia Hospital | Breda | Noord-Brabant |
Netherlands | Albert Schweiter Hospital | Dordrecht | Zuid Holland |
Netherlands | Catharina Hospital | Eindhoven | Noord-Brabant |
Netherlands | Martini Hospital | Groningen | |
Netherlands | Elkerliek Hospital | Helmond | Noord-Brabant |
Netherlands | Spaarne Gasthuis | Hoofddorp | Noord-Holland |
Netherlands | Haga Ziekenhuizen | Zoetermeer | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | Amsterdam UMC, University of Twente, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health outcomes and quality of life | 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) | Baseline, 6 and 12 months after intervention | |
Other | Use of hospital resources | According to medical records | 1 year post-intervention | |
Other | Medical consumption | iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire) | 1 year post-intervention | |
Other | Use of healthcare resources | iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire) | 1 year post-intervention | |
Other | Cumulative cost | Based on Rijnstate price estimates | 1 year post-intervention | |
Other | Fractional nodal uptake | Assessed by I-123 or I-131 scintigraphy | 1 year post-intervention | |
Other | Treatment related auto-immunity | Assessed by thyroid antibodies | Baseline and 1 year post-intervention | |
Primary | Hypothyroidism | Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels) | 1 year post-intervention | |
Secondary | Cure rate | Medication-free normalization of TSH, FT4 and FT3 levels | 1 year post-intervention | |
Secondary | Thyroid nodule volume | Volume of thyroid nodule assessed by ultrasound | Baseline, 6 and 12 months post-intervention | |
Secondary | Treatment related adverse events | Number of adverse and serious adverse events | 6 weeks and 3, 6 and 12 months post-intervention | |
Secondary | Thyroid related quality of life | Thyroid related quality of life assessed by ThyPro questionnaire | Baseline, 6 and 12 months after intervention | |
Secondary | Cost-effectiveness | Determined as the incremental costs in Euros per quality adjusted life year (QALY) | Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention | |
Secondary | Course of thyroid function | Assessed by TSH, FT4 and FT3 an medication use | Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years. | |
Secondary | 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'). | 1 week and 1 year post-intervention |
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