RFA for Benign Thyroid Nodules—Is a Sham‐Controlled RCT Justified or Practical?

In “Benign symptomatic thyroid nodules—a place for a randomized trial of sham procedure versus radiofrequency ablation?” [1]. Morton calls for a randomized controlled trial (RCT) comparing radiofrequency ablation (RFA) to a sham procedure for benign symptomatic thyroid nodules. The purpose of this proposal is to examine the true symptomatic benefit of the intervention. The perspective article also explores many of the potential barriers to such a RCT, including the associated cost, challenges in designing a sham procedure, and ethical considerations. Over the past two decades, RFA to treat patients with symptomatic nodules has gained widespread acceptance internationally. It is now endorsed by most major international thyroid societies including the American Thyroid Association [2], the European Thyroid Association [3], and the Korean Society of Thyroid Radiology [4]. These guidelines consistently recommend RFA for benign nodules causing compressive symptoms or cosmetic concerns, as validated by long-term outcomes data. One safety parameter that all guidelines mandate is that nodules have benign cytology confirmed on at least two fine-needle aspirations (FNA), with the exception of spongiform nodules and hyperfunctional nodules, where one biopsy may be appropriate. This is to avoid inadvertently and inappropriately treating a malignant lesion large enough to cause compressive symptoms with RFA. The symptomatic improvement from RFA is well-documented, with studies reporting symptom relief in up to 89% of cases [5-8]. and maintained volume reduction in the majority of patients with nodules < 15–20 mL in size [9]. Nodules of larger baseline volumes (> 20–30 mL) have a higher likelihood of regrowth and are more likely to need repeat ablations. This is an important counseling consideration for patients with large volume disease. While there is no data on RFA compared to sham procedure, there is unequivocal and consistent published data from numerous countries demonstrating benefits of RFA over observation and equivalence of RFA compared with surgery for symptomatic relief. Therefore, based on these data and the established equivalence between the two techniques, questioning the efficacy of RFA would similarly challenge surgical efficacy. As the prevalence of thyroid nodules continues to increase, whether due to detection bias or otherwise, there is a growing clinical need for viable alternatives to surgery. RFA is such an alternative for well-selected and informed patients. However, despite the technique being well-established overseas, with good efficacy and safety records, RFA remains relatively novel in Australia, with limited practitioner uptake and without Medicare item number for reimbursement. The limited clinician uptake reflects, in part, the need for a more integrated training approach for registrars and early career practitioners—one that incorporates procedural proficiency in ultrasound-guided interventions with clinical expertise in caring for patients with thyroid pathology. In situations where two or more treatment options have been shown to provide a similar effectiveness and safety profile, other factors may assume more relevance in the decision-making process. These include, but are not limited to, cost-effectiveness analysis, patient suitability and preference, local expertise when it comes to procedural treatments, and access to treatment. It is important that patients are counseled regarding their options and have the opportunity to discuss the merits and potential pitfalls of each option. As specialty practitioners, thyroid clinicians have a responsibility to our patients to be aware of all appropriate treatment options available. International studies consistently demonstrate that RFA is more cost-effective than surgery for benign thyroid nodules, though they mostly focus on the initial treatment episode. Recent studies by Kuo et al. and Schalch et al. reported that RFA conferred a $2699 cost saving per patient and superior quality-adjusted life years in the United States (with the cost of surgery quoted at over $19 000), while the Brazilian prospective study reported a 24% cost reduction compared to surgery [10, 11]. Ablation procedures are designed to be performed in an outpatient setting, which has significant cost saving implications by eliminating operating room usage. However, there remains a critical knowledge gap in the Australian healthcare context. No Australian cost-effectiveness studies have been conducted comparing RFA with thyroid lobectomy for benign nodules. This absence of locally relevant economic evaluation represents a significant research priority, particularly given Australia's unique healthcare delivery model of a mixed insurance and Medicare system. Appropriate patient selection remains paramount for successful thyroid RFA outcomes, as the procedure presents unique clinical considerations that distinguish it from surgical resection. Unlike surgery, which provides immediate definitive treatment, RFA induces gradual volume reduction over 6–24 months, with most shrinkage occurring within the first 1–3 months and continuing progressively. This delayed therapeutic effect necessitates careful patient counseling regarding realistic expectations and timeline for symptom improvement. Following RFA, changes to the ultrasonic appearance of treated nodules can complicate future surveillance, potentially masking or mimicking malignant features on follow-up imaging. However, although nodule appearance does change after ablation, there are established and well-documented “expected” ultrasound characteristics for post-ablation nodules. Therefore, ablated nodules can be safely followed so long as physicians understand what is normal and what is abnormal for a nodule post-ablation. The risk of nodule regrowth is also a unique consideration post-ablation, occurring in 13%–24% of cases, especially for larger baseline volume nodules. These factors underscore the importance of meticulous pre-procedural evaluation, comprehensive patient education, and establishment of robust long-term surveillance protocols. As thyroid RFA is already an established therapeutic option in many countries, the Australian surgical community faces both an opportunity and an obligation to critically evaluate its integration into local practice. While the pursuit of high-quality evidence is essential, the call for a sham-controlled RCT of RFA for benign thyroid nodules may be a case of methodological idealism over clinical pragmatism. International consensus already supports RFA for appropriately selected patients, and the symptomatic benefit is well-established. A more practical approach would involve prospective observational studies, registries, and cost-effectiveness analyses to further validate RFA's role in clinical practice and to compare RFA to thyroid lobectomy. The successful implementation of thyroid RFA in Australia will require practitioners to develop advanced ultrasound and biopsy skills which can be transferred to performing ablative procedures safely; attend ablation training programs as part of their clinical training; secure adequate Medicare and insurance support; and conduct local research to guide evidence-based practice within the healthcare system. Ultimately, the goal should be to align Australian practice with international standards, ensuring patients have access to minimally invasive options that improve quality of life and reduce surgical burden. The authors declare no conflicts of interest. Data sharing not applicable to this article as no datasets were generated or analysed during the current study.