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Switched from RCT to observational prospective cohort due to termination of subsidy (delay due to insufficient inclusion-rate). Follow-up of RCT-arm will be completed. Patients can still be included in a observational cohort.
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| University of Twente | OTHER |
| Amsterdam UMC | OTHER |
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The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation | Experimental | Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique. |
|
| Radioactive iodine, study protocol | Active Comparator | Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation. |
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| Radioactive iodine, cohort | Other | This group contains patients who are not randomized and have given informed consent undergo treatment with radioactive iodine (I-131) according to local standard (e.g. fixed dose or dose-calculation based on iodine uptake and thyroid nodule mass). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Device | Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypothyroidism | Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels) | 1 year post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | Medication-free normalization of TSH, FT4 and FT3 levels | 1 year post-intervention |
| Thyroid nodule volume | Volume of thyroid nodule assessed by ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Use of hospital resources |
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Groep Twente | Almelo | Gelderland | 7609PP | Netherlands | ||
| Gelre Hospitals |
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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.
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| Radioactive iodine | Drug | I-131 according to standardized doses-calculation. |
|
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| Radioactive iodine | Drug | I-131 according to local standard. |
|
|
| Baseline, 6 and 12 months post-intervention |
| Treatment related adverse events | Number of adverse and serious adverse events | 6 weeks and 3, 6 and 12 months post-intervention |
| Thyroid related quality of life | Thyroid related quality of life assessed by ThyPro questionnaire | Baseline, 6 and 12 months after intervention |
| 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 |
| 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. |
| 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 |
According to medical records |
| 1 year post-intervention |
| Medical consumption | iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire) | 1 year post-intervention |
| Use of healthcare resources | iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire) | 1 year post-intervention |
| Cumulative cost | Based on Rijnstate price estimates | 1 year post-intervention |
| Fractional nodal uptake | Assessed by I-123 or I-131 scintigraphy | 1 year post-intervention |
| Treatment related auto-immunity | Assessed by thyroid antibodies | Baseline and 1 year post-intervention |
| Apeldoorn |
| Gelderland |
| 7334DZ |
| Netherlands |
| Rijnstate Hospital | Arnhem | Gelderland | 6815AD | Netherlands |
| Laurentius Hospital | Roermond | Limburg | 6043CV | Netherlands |
| Amphia Hospital | Breda | North Brabant | 4818 | Netherlands |
| Catharina Hospital | Eindhoven | North Brabant | 5623EJ | Netherlands |
| Elkerliek Hospital | Helmond | North Brabant | 5707HA | Netherlands |
| Amsterdam UMC, location VUMC | Amsterdam | North Holland | 1081HV | Netherlands |
| OLVG | Amsterdam | North Holland | 1091AC | Netherlands |
| Spaarne Gasthuis | Hoofddorp | North Holland | 2134 TM Hoofddorp | Netherlands |
| Albert Schweiter Hospital | Dordrecht | South Holland | 3318AT | Netherlands |
| Haaglanden MC | The Hague | South Holland | 2512VA | Netherlands |
| Haga Ziekenhuizen | Zoetermeer | South Holland | 2725 NA | Netherlands |
| Martini Hospital | Groningen | 9728 NT Groningen | Netherlands |
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D020728 | Transurethral Resection of Prostate |
| C000614965 | Iodine-131 |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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