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

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:

Single site study at Royal Berkshire NHS Foundation Trust.

10 patients will be recruited to the study. Participants will have been diagnosed with an enlarged thyroid gland which is causing local neck symptoms (e.g. pressure or tightness), cosmetic issues or thyroid overactivity.

• Patient will be first seen and assessed by the ENT team or Interventional Radiology Consultants who confirm the patient has non-cancerous thyroid nodules and requires treatment for their thyroid disease. This is standard care.
• All patients are then seen by the ENT team (if not already seen). The ENT team consider whether the patient is suitable for study inclusion and discuss possible study participation with the patient. The ENT team provide a study patient information sheet (PIS) and after care advice sheet at this time. With the patients permission the ENT team provides the patients contact details to the research study team (via hospital email or electronic messaging). The ENT team will also document study discussion in the patients electronic records. (10 minutes)
• Study team contacts the patient by telephone and discusses the study. Patient questions addressed. Telephone consent obtained. Patient sent a copy of the consent form prior to their study pre-assessment clinic (by email or paper form by post). (20 minutes)

If individuals require more time to consider participation they will be contacted again at an agreed time.

• Potential participants will attend a screening visit in the Interventional Radiology department at RBFT. The following investigations would then be performed / arranged: ultrasound, needle tests of thyroid gland, CT and blood tests.

(40 minutes).

• Study team (principle investigator) assesses all results of the screening visit. If the patient meets study inclusion criteria, study team (research nurse) liaises with Radiology booking team and arranges TAE treatment date. Patient and GP informed by letter/email. Patient will be sent a quality of life questionnaire by post or email (30 minutes).

If any results indicate TAE is unsuitable (e.g. abnormal needle test result) the patient will be referred back to the ENT team for standard care.

• Study intervention (TAE) performed. (3 hours which includes arrival, admission and procedure time).

(Please note an external expert who is highly experienced in TAE will be present for the first two cases. They will only observe and advise where necessary)

• Patient monitored in Radiology recovery area for 4 hours after procedure (4 hours)

• Patient admitted to ENT ward for overnight observations and then discharged by research team the following day (approximately 16 to 24 hours)

• One week post procedure telephone appointment: Analgesia questionnaire and adverse event score completed (can also be sent by post or email and returned by post or email if required). (30 minutes)

• 3 months post procedure appointment: Quality of life questionnaires; Local symptom and cosmetic scores (out of 10); Thyroid function blood tests; Thyroid volume on ultrasound or CT arranged if required (1h)

• 6 months post procedure appointment: Quality of life questionnaires; Local symptom and cosmetic scores (out of 10); Thyroid function tests; Thyroid volume on ultrasound or CT arrange if required (1h)

(Please note clinical assessment / evaluations will be undertaken outside these time points if clinically indicated).

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.