Radiofrequency ablation or Hemithyroidectomy for benign intrathyroidal tumours Ear, Nose and Throat
Conditions
Interventions
RANDOMISATION
Randomisation will be provided by BCTU using a secure online system. Unique log-in usernames will be provided to those who wish to use the online system and who have been delegated the
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Thyroid nodule assessed as benign on an ultrasound scan (USS) and fine needle aspiration cytology (FNAC) (U2/TIRADS2 and 1 X Thy2 OR U3/TIRADS3 and 2 x Thy2) 3. Nodule criteria: Total volume of nodule 0.1mIU/L and 0.1 mIU/L and < lower limit of the local reference range 9. International Normalised Ratio (INR) < = 1.5 10. Activated Partial Thromboplastin Time (aPTT) < the maximum value of 10% greater than the upper limit of the local reference range 11. Willing and able to provide written consent 12. Willing to undergo randomisation
Exclusion criteria
Exclusion criteria: 1. Contraindication to thyroid surgery or RFA 2. Any previous surgery to the central neck compartment 3. Previous treatment for thyroid disorders 4. Previous thyroid RFA 5. Previous radioactive iodine treatment 6. Previous radiotherapy which included the neck 7. Current treatment with antithyroid drugs or thyroid hormone replacement 8. Known pregnancy 9. Formal anticoagulation that cannot be paused for the intervention, or documented bleeding diathesis 10. Clopidogrel that is not able to be stopped for a minimum of 5 days prior to the intervention 11. Aspirin that is more than the maximum dose of 75 mg once daily 12. Prosthetic heart valve, pacemaker, or any other implanted cardiac device 13. Other malignant nodules or nodules with indeterminate cytology in either lobe 14. Pre-existing vocal cord palsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Goitre symptom score at 12 months post intervention- using the goitre domain of the ThyPRO tool 2. Cost effectiveness at 12 months 2.1. Health related quality of life (using the EQ-5D-5L questionnaire) 2.2. Health resource usage (HRUQ questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite ThyPRO score (overall quality of life) at 12 months post intervention 2. ThyPRO domain scores for: hyperthyroid symptoms, hypothyroid symptoms, eye symptoms, tiredness, cognition, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, impaired sex life and cosmetic complaints. All at 3, 12, 24 and 36 months post intervention 3. Incidence of complications within 3 months post intervention 4. Incidence of hypothyroidism up to 36 months post intervention 5. Incidence of temporary or permanent recurrent laryngeal nerve palsy at 12 months post intervention 6. Percentage volume reduction in treated nodule(s) at 12 months post intervention (RFA arm only) 7. Need for additional procedures related to the condition or treatment received up to 36 months post intervention 8. Nodule recurrence at 36 months post intervention assessed by USS (RFA arm only) 9. Pain intensity (related to pre-existing pain levels and the procedure – measured using pain VAS) at immediately post-intervention, 3, 12, 24, and 36 months post intervention 10. Related re-admission to hospital within 30 days of the initial trial intervention 11. Acceptability of RFA to patients (determined by take-up at screening) | — |
Countries
England, United Kingdom
Contacts
Public ContactSmita Odedra
Outcome results
None listed