RABBIT
Research type
Research Study
Full title
Radiofrequency Ablation of Benign Intrathyroidal Tumours
IRAS ID
335450
Contact name
Neil Sharma
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Thyroid nodules are a very common cause of neck lumps. Most nodules are confirmed to be benign by ultrasound scan (US) and fine needle aspiration cytology (FNAC). These nodules can be left alone if they are not causing any troublesome symptoms. Some benign nodules grow to a size that can cause local symptoms such as pressure or pain or they can become unsightly to an individual. If treatment is required, the standard option is surgery with removal of either part of or the whole thyroid gland but it may not be suitable for everyone. The introduction of radiofrequency ablation (RFA) has opened up a less invasive treatment option. The Rabbit trial will directly compare RFA to surgery as a treatment for thyroid nodules. It will help us find out whether RFA is as effective as surgery for symptom reduction, and if it is associated with fewer complications, improved cost effectiveness and overall acceptability. We are looking to recruit 448 patients aged 18 years or older with single or multiple thyroid nodule(s) that are causing compressive or cosmetic symptoms affecting their quality of life. Thyroid nodules must be assessed as benign on an ultrasound scan and FNAC (U2/3 or TIRADS 2/3 AND Thy2). We will invite participants from secondary/tertiary care thyroid surgery/endocrinology departments in approximately 20 UK centres. Participants will be randomised to either RFA or hemithyroidectomy. Follow up appointments in clinic will occur at 3 months, 12 months and 36 months including physical assessments, thyroid function tests, and RFA participants will undergo US. All participants will be asked to complete questionnaires at 3 months, 12 months, 24 months and 36 months. At the end of the trial, participants will continue with standard of care with their usual clinical team.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0299
Date of REC Opinion
3 Oct 2024
REC opinion
Favourable Opinion