Authors' objectives: Background: Benign thyroid nodules occur in up to 60% of the general population and the vast majority of such nodules are non-toxic, i.e. not producing excess thyroid hormone. Non-toxic nodules are usually asymptomatic but may give symptoms such as difficulty swallowing. Management for non-toxic nodules is usually observation although surgery (usually hemi- or subtotal/total thyroidectomy), or hormone therapy may be needed in some cases. Toxic nodules need treatment, usually radioactive iodine therapy, anti-thyroid medication or surgery. Graves' disease, an autoimmune disorder with excess thyroid hormone production, is managed with antithyroid medications, radioactive iodine, or thyroidectomy. Thermal ablation (TA), a minimally invasive technique using heat induced by radiofrequency, microwave or laser, has emerged as an alternative to surgery for benign thyroid nodules or Graves' disease. Question at issue: Is radiofrequency ablation (RFA) or microwave frequency ablation (MWA) an effective and patient safe alternative, compared with thyroid surgery, for treatment of adult patients with benign non-toxic or toxic nodules, and toxic diffuse autoimmune hyperthyroidism (Graves' disease)?

Authors' results and conclusions: Results Twenty-five reports (four RCTs, 14 cohort studies and seven case series) were included in the assessment. All comparisons are RFA or MWA compared with surgery in adults. Benign non-toxic (P1) and toxic thyroid (P2) nodules if not otherwise stated Critical outcomes were all assessed as very low certainty of evidence (GRADE ⊕OOO). Thus, it is uncertain whether there is any difference for TA versus surgery regarding mortality (reported in one RCT with zero events), health-related quality of life (two RCTs and four cohort studies), symptom change (one RCT and three cohort studies), complications (four RCTs, and 13 cohort studies), relapse (three cohort studies) and reintervention (four cohort studies). The frequency of malignancy was reported in two cohort studies with zero detected events by ultrasound and fine needle biopsy in the TA group, while 9% malignancies were detected in the specimens resected in the surgery group. There were no specimens for microscopy in the TA group, and thus the true frequency of malignancy is unknown. Important outcomes: Operation time was reported in three RCTs, and in ten cohort studies. Data from two RCTs were pooled in a meta-analysis with reduced operation time for TA compared with surgery, MD: -77.64 (95%CI: -93.40 to –61.88) min., p<00001, and from eight cohort studies, MD: -52.15 (95% CI: -62.06 to –42.23) min., p<0.00001. Conclusion: Operation time is probably reduced with TA compared with surgery (GRADE ⊕⊕⊕O). Volume reduction was reported in two RCTs, and twelve cohort studies. For the RCTs, the mean volume reduction at 12 months for TA was 79.79 (95% CI: 79.02; 80.55) % while it was 82.59 (95% CI: 77.06; 90.10) % for seven cohort studies. Volume reduction for surgery was not reported but is supposedly usually 100% (hemithyroidectomy). Conclusion: Nodule volume reduction after TA at 12 months of follow-up is approximately 80%. Biochemical response in terms of TSH (Thyroid stimulating hormone) levels was reported in four cohort studies, three of which could be pooled in a meta-analysis with MD: -0.38 (95% CI: -0.98 to 0.22) µU/L, n.s. Conclusion: It is uncertain whether there is any difference in biochemical response with TA compared with surgery (GRADE ⊕OOO). Need of postinterventional hormonal treatment was reported in one RCT, Zhi et al. (2018) (n=52) with 0/28 events in the TA and 1/24, in the surgery group, n.s., and in seven cohort studies with a Peto OR of 0.11 for P1 (5 cohorts) and 0.05 for P1 + P2 (2 cohorts). Conclusion: TA may reduce the need of hormone replacement compared with surgery (GRADE ⊕⊕OO). Hospital stay was reported in two RCTs and data were pooled in a meta-analysis, with MD: -3.14 (95% CI: -4.80 to -1.48) days, p=0.0002. Results from eight of the cohort studies could be pooled with MD: -3.59 (95% CI: -4.46 to -2.71) days, p=0.00001. Conclusion: The length of hospital stay may be reduced with TA compared with surgery (GRADE ⊕⊕OO). Graves' Disease in adults (P3) No controlled studies were identified for TA compared with surgery. One of three case series reported complications in 10/50 (20%) patients. Conclusions Twenty-five studies mainly from Asia, four small RCTs, 14 non-randomised controlled studies and seven case series were identified evaluating RFA or MWA compared with conventional surgery. For all critical outcomes, the available evidence does not allow any conclusions about effectiveness and safety for TA compared with surgery. Regarding outcomes important for decision making, operation time and the need of hormonal replacement are probably reduced, while hospital stay may be reduced when comparing TA with surgery. Complications with TA are not infrequent and may be severe, as also for surgery, and the incidence and impact of missed malignancies after TA are poorly known. There is an absence of high-quality well-designed large RCTs evaluating critical outcomes for TA compared with surgery.

Authors' methods: Methods After definition of PICO, systematic literature searches were conducted in Medline (OvidSP), Embase (OvidSP), and Web of Science Core Collection, and websites of Scandinavian HTA-organisations. Two authors screened the obtained abstracts and made a first selection of full-text reports which were then read by at least two authors, and it was finally decided in consensus which reports should be included. Included studies were critically appraised using checklists. Data was extracted by at least two authors, summarised for each outcome and when possible, pooled in a meta-analysis. The certainty of evidence for each outcome was assessed using the GRADE approach. Summary of the results per outcome and the associated certainty of evidence were presented in a Summary-of-findings table.

Project Status: Completed

Year Published: 2025

URL for published report: https://mellanarkiv-offentlig.vgregion.se/alfresco/s/archive/stream/public/v1/source/available/sofia/su4372-2081313122-154/native/2025_142%20HTA-rapport%20Thermal%20ablation%20thyroid%202025-06-30.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Organisation Name: The Regional Health Technology Assessment Centre

Contact Address: The Regional Health Technology Assessment Centre, Region Vastra Gotaland, HTA-centrum, Roda Straket 8, Sahlgrenska Universitetssjukhuset, 413 45 GOTHENBORG, Sweden

Contact Name: hta-centrum@vgregion.se

Contact Email: hta-centrum@vgregion.se