Large non-cancerous thyroid nodules (lumps in the thyroid gland) can cause pressure or discomfort in the neck or cosmetic issues. The standard treatment options include radiofrequency ablation, radioactive iodine, and surgery. Not all patients are suitable however for these treatments, some lumps are too large, or the patients are not fit enough for surgery.
Thyroid artery embolization (TAE) is a new minimally invasive technique (smaller incisions / cuts and shorter recovery time) performed under light sedation. It is used by other European Thyroid Centres, but it hasn't been used in the UK. Embolization means arteries supplying the thyroid gland are blocked by injecting small occlusive particles, like very fine grains of sand that can get stuck in small spaces, preventing blood from passing through. Blocking the thyroid arteries causes the gland to shrink. This provides symptom relief or controls an overactive gland.
We aim to undertake a TAE pilot study to explore the safety of TAE in a UK patient population. We are planning to recruit 10 eligible patients. We will also collect additional data (for example on pain, effectiveness, cost and health related quality of life) to inform a future larger trial comparing TAE to other treatment options.
Adults over 18 years of age willing and able to give informed consent.
Symptomatic or cosmetically distressing benign nodular thyroid disease with or without intrathoracic extension and with or without hyperthyroidism. Or auto-immune hyperthyroidism (Graves disease).
Single nodular goitre causing local mass effect warranting treatment or multi-nodular goitre
TIRADS score 1, 2 and 3 nodules (benign or mildly suspicious) as assessed by ultrasound.
Adults over 18 years of age willing and able to give informed consent.
Symptomatic or cosmetically distressing benign nodular thyroid disease with or without intrathoracic extension and with or without hyperthyroidism. Or auto-immune hyperthyroidism (Graves disease).
Single nodular goitre causing local mass effect warranting treatment or multi-nodular goitre
TIRADS score 1, 2 and 3 nodules (benign or mildly suspicious) as assessed by ultrasound.
Single group
Thyroid artery embolization
Procedure/SurgeryA minimally invasive procedure where one or more thyroid arteries are occluded to shrink the thyroid gland or thyroid nodules
Primary outcome measure
To undertake thyroid artery embolisation (TAE) pilot study and make a preliminary (non-powered) evaluation of TAE safety. The primary end-point is safe treatment with TAE of 10 patients over an 18 month period.
Recruitment
Assess difficulties in recruiting patients by monitoring patient recruitment to time and target
Procedural pain
Procedural pain (Pain score, analgesia use and adverse event recording at 1 week (7 to 10 days).
Procedural outcome
Pre-TAE and 3 and 6 months post TAE: Procedural effectiveness (patient reported symptom and cosmetic scores, thyroid function blood tests, ultrasound (+/-CT assessment) before and at time intervals after TAE). Pre-TAE and 3 and 6 months post TAE: Health related quality of life impact (Questionnaires before and at time intervals after procedure)
Cost
At study end: Assess cost effectiveness - analysis by Trust financial analyst will be undertaken
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Royal Berkshire NHS Foundation Trust
Lead sponsor
University of Reading
Collaborator
