Radiofrequency ABlation of Benign Intrathyroidal Tumours

Research question: Is radiofrequency ablation (RFA) for benign thyroid nodules compared to conventional open surgery non-inferior for: 1 Patient symptom reduction 2 Cost effectiveness 3 Quality of life In addition, will RFA show reduced complication rates (hypothyroidism, recurrent laryngeal nerve injury) Background: Thyroid nodules are common, palpable in 5-7%, and evident on ultrasound in 50-60% of people. Their diagnostic pathway is well established and determines nodule function and its malignancy risk, stratifying those that require further treatment. Most thyroid nodules are benign and do not need treatment, but they may cause compressive symptoms. Historically, the therapy for compressive nodules is thyroid surgery. Recent percutaneous thermal ablative techniques are less invasive options. RFA is NICE-approved to treat benign thyroid nodules and clinical and cost-effectiveness evaluation has been recommended. Few randomised controlled trials have examined the efficacy of RFA versus standard surgery for symptom reduction, complications, cost effectiveness and acceptability. Aims and objectives: To compare RFA and standard of care conventional hemithyroidectomy for symptom reduction and cost effectiveness. Primary outcomes (12 months): 1 Goitre symptom score 2 Cost effectiveness Secondary outcomes: 1 Composite ThyPRO score 2 Complication rate/adverse events 3 Percentage volume reduction in treated nodule(s) at 12 months 4 Acceptability of RFA 5 Need for additional related procedures 6 Nodule recurrence 7 Pain intensity 8 Related re-admission within 30 days of procedure Methods: Pragmatic multicentre randomised non-inferiority trial with 1:1 randomisation to compare hemithyroidectomy with RFA. Patients will be >18 years, euthyroid, with evidence of compression or cosmetic symptoms from their benign thyroid nodule(s). Symptoms will be assessed through the ThyPro questionnaire goitre domain. A comprehensive training programme will be provided to accredit UK thyroid radiologists in thyroid RFA, in 20-30 UK centres. Patients will be followed with thyroid function and vocal cord checks at appropriate intervals. Nodule volume, symptoms, quality of life, pain intensity and health economic data will be collected during 3 years follow-up. We will recruit 224 patients in both RFA and surgery groups to determine if RFA is inferior to surgery. Totally 448 patients will be recruited from 20-30 UK centres (2 patients/centre/ month). Analysis will be on intention to treat basis and health economic evaluation of relative cost-effectiveness of RFA compared with surgery. Timelines for delivery: 0-6 months: approval 7-16 months: set up and training 7-23 months: recruitment 24-59 months: follow-up 60-65 months: analysis/write-up Anticipated impact and dissemination: If RFA is equivalent to surgery for symptom reduction and more cost effective, and, secondarily, at least equivalent or better for complications, this will promote the wide use of RFA across the UK for benign thyroid disease, serve patients better and be cost-efficient. Effective communication of results will be through presentation at clinician and patient events, high impact publications, webinars, newsletters and social media. The trial is an exemplar of close collaboration between endocrinologists, surgeons and radiologists strengthened by longstanding close links with thyroid disease patient-led groups.