Thyroid Artery Goitre Embolization Trial A Pilot Study Investigating Thyroid Artery Embolisation as a Treatment for Large Thyroid Nodules

Summary

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.

Eligibility

Inclusion Criteria:

* The participant may enter the study if ALL of the following apply:

  * 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.
  * FNA confirmed benign disease (x2 FNA Thy2 (benign) result required for TR3 nodules, 1x FNA if nodule classified TR2 or less). FNA performed on most high grade nodule or if equal grade then largest nodule.
  * No enlarged / suspicious neck lymphadenopathy on ultrasound.
  * Patient willing to undergo thyroid nodule embolization in preference to other viable treatment options after discussion with Consultant ENT surgeon and / or Consultant Interventional Radiologist. TAE can also be performed as a bridge to surgery, Radiofrequency ablation or Radioactive iodine. Patients may also be unsuitable or unfit for other treatment options.
  * Patient able to lay on the angiography table flat with one or two pillows, and can lay comfortably with 30 degrees or less of head elevation for a minimum of two hours.

Exclusion Criteria:

* The participant may enter the study if ALL of the following apply:

  * 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.
  * FNA confirmed benign disease (x2 FNA Thy2 (benign) result required for TR3 nodules, 1x FNA if nodule classified TR2 or less). FNA performed on most high grade nodule or if equal grade then largest nodule.
  * No enlarged / suspicious neck lymphadenopathy on ultrasound.
  * Patient willing to undergo thyroid nodule embolization in preference to other viable treatment options after discussion with Consultant ENT surgeon and / or Consultant Interventional Radiologist. TAE can also be performed as a bridge to surgery, Radiofrequency ablation or Radioactive iodine. Patients may also be unsuitable or unfit for other treatment options.
  * Patient able to lay on the angiography table flat with one or two pillows, and can lay comfortably with 30 degrees or less of head elevation for a minimum of two hours.

Conditions4

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