Thyroid ARtery Goitre Embolization Trial: A Service Introduction and Safety Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary outcome measure
研究概览
简要总结
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.
详细描述
Justification:
Large thyroid nodules in the neck can cause local pressure symptoms and cosmetic issues. Current treatment options include radioactive iodine (RAI), radiofrequency ablation (RFA) and surgery but larger nodules are difficult to shrink or remove and are associated with risks that some patients find unacceptable such as an underactive thyroid gland which requires life long tablets and surgical scars. Larger nodules are also more difficult to remove surgically.
Thyroid artery embolisation (TAE) is a new procedure for non-cancerous thyroid nodules which are causing local symptoms or hyperthyroidism (overactive thyroid glands). TAE involves blocking thyroid arteries using tiny particles introduced via a small tube (catheter). The tube is guided to the thyroid artery under x-ray guidance. In published studies TAE has been used in small numbers of patients with large thyroid glands where other treatment options are difficult. Evidence shows TAE is safe and improves thyroid function in patients with an overactive gland. TAE also causes gland shrinkage (between 40% to 70%) and improves local neck symptoms (like tightness or pressure), cosmetic appearance and quality of life.
Early research indicates TAE is promising but wider use of the procedure is limited by a lack of high-quality research with larger numbers of patients. It has also never been evaluated in the NHS or UK. We therefore aim to undertake the first UK feasibility study into TAE to primarily evaluate safety. This study will help inform a future larger trial to understand how effective TAE is.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary outcome measure
时间窗: 18 months
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.
次要结局
- Procedural pain(1 week)
- Cost(24 months)
- Recruitment(18 months)
- Procedural outcome(3 and 6 month follow up)
- Procedural pain(1 week)
- Cost(24 months)