Radiofrequency ABlation of Benign Intrathyroidal Tumours (RABBIT)
Radiofrequency ablation or Hemithyroidectomy for benign intrathyroidal tumours
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 role of randomising participants into the trial as detailed on the delegation log. These unique log-in details must not be shared with other staff and in no circumstances should staff at sites access the system using another person’s login details. The online system will be available 24 hours a day, 7 days a week, apart from short periods of scheduled maintenance. In the rare event of the online system being unavailable, the local research team will contact the BCTU Trial Office (between 9am and 5pm) who will randomise the participant using an emergency paper backup, the details from which will later be added to the database. TRIAL INTERVENTION Participants will be randomised to receive either radiofrequency ablation or hemithyroidectomy. Radiofrequency ablation If the participant is randomised to the RFA arm, a request for the procedure will be made in line with local process. The procedure will be carried out by the appropriately trained and delegated clinician (on the SSDL). The procedure will be carried out as per the RABBIT RFA Manual taking into account any pre-existing local RFA guidance. Further repeat RFA treatment will be at the discretion of the local PI, based on the clinical need of the participant. This should be documented on the Repeat RFA eCRF. Hemithyroidectomy If the participant is randomised to the surgery arm, they will be listed for hemithyroidectomy in line with the local process. The hemithyroidectomy, including any pre-operative assessments and admission procedures, will be carried out as per the local SOP and guidelines. PROCEDURES AND ASSESSMENTS SCREENING A medical history will be taken during the screening period to confirm eligibility and to capture any relevant conditions related to the thyroid and when these started or were diagnose
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 < = 50cm3 4. Nodule consistency: Either 1) Solid, 2) Mixed solid and cystic (< = 60% cystic), or 3) Microcystic (0-100%) 5. Absence of retrosternal content 6. Clinical/radiological evidence of compression or cosmetic concerns ascribed to unilateral thyroid nodule/s and NOT to bilateral nodules or diffuse goitre 7. Thyroid Stimulating Hormone (TSH) > 0.1mIU/L and < upper limit of local reference range 8. Free T4 within the local reference range if TSH > 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
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