Radiofrequency ablation for patients with primary hyperparathyroidism: a multicenter non-randomized open-label single-arm prospective clinical trial

Objectives: To evaluate the efficacy, safety, and factors influencing the response to radiofrequency ablation (RFA) in patients with primary hyperparathyroidism (PHPT) in a prospective multicenter trial. Materials and methods: Between September 2022 and June 2024, 34 patients with 35 parathyroid lesions who either refused surgery or were ineligible for it underwent RFA for treatment of PHPT across three hospitals. Nodule size, volume, and biochemical data were compared before and after treatment (at 2 h, 1 week, and 1, 3, 6, and 12 months). Complications were assessed during and after treatment. Factors influencing the treatment response to RFA for PHPT were analyzed. Results: Significant reductions in nodule size and volume, as well as improvements in serum parathyroid hormone (PTH) and total calcium levels, were noted at the 3-, 6-, and 12-month follow-ups after RFA (all p < 0.05). Out of the 34 patients, 17 experienced a complete response with normalized serum PTH and calcium levels (50.0%), whereas 17 showed a partial response (50.0%) (median number of sessions 1). The initial serum PTH level was a key factor associated with the treatment response to RFA, with an area under the receiver operating characteristic curve of 0.853 using a PTH cutoff value of ≥ 118 pg/mL. Transient voice change (n = 1) and hypocalcemia (n = 1) were reported after the procedure. Conclusion: In selected cases, RFA is a safe and effective treatment option for patients with PHPT. The initial PTH level of < 118 pg/mL is associated with achieving a biochemical cure after a single treatment. Key Points: Question The efficacy of radiofrequency ablation in treating primary hyperparathyroidism remains unclear due to limited evidence, highlighting the need for further study. Findings In this prospective multicenter study, the complete response rate was 50.0%, with 79.4% achieving normocalcemia. Baseline serum parathyroid hormone levels significantly influenced treatment response. Clinical relevance Radiofrequency ablation is a safe and effective treatment for selected patients with primary hyperparathyroidism, especially those who are ineligible for surgery. Initial serum parathyroid hormone levels predict the likelihood of achieving a biochemical cure after a single treatment.