Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Megadott ok: 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.
A legfontosabb adatok
- Fázis
- 3. fázis
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A vizsgálat adatai
- Ki végzi
- Rijnstate Hospital
- Azonosító
- NCT05142904
- A regiszteradat frissítve
- 2025. július 17.
- Eredeti leírás
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; Multifocal HTN; HTN > 50 mm; Presence of a medical device susceptible to disturbances caused by RFA generated currents; Uncorrectable haemorrhagic diathesis; Pregnant or breastfeeding women.