Comparison of the two treatment methods in primary hyperparathyroidism due to solitary parathyroid adenoma, Ultrasound-guided percutaneous alcohol ablation vs. parathyroidectomy: a randomized controlled trial

Abstract

Background: Primary hyperparathyroidism (pHPT) is the third most common endocrine system disorder. Parathyroidectomy (PTx) is the gold standard of care in symptomatic patients. Patients who are not surgical candidates may benefit from percutaneous ethanol ablation, which is a minimally invasive procedure. This study aims to evaluate the effectiveness and safety of PTx vs. PEA.

Method: A single-centered randomized, not-blinded parallel clinical trial in consecutive patients with pHPT treated with percutaneous alcohol ablation (PEA) between January 2020 and November 2021. Patients with a confirmed solitary parathyroid adenoma and a biochemically verified pHPT were randomly enrolled in the PTx or PEA groups. Complications and lab data were evaluated 24 h, 2 weeks, 3 months, and 6 months following interventions. Effectiveness was defined as complete response (normal calcium and PTH), partial response (reduced but not normalized PTH with normal serum calcium), or disease persistence (elevated calcium and PTH). SPSS 22.0 was used for statistical analysis.

Result: The final sample comprised 68 patients in each group which 113 of whom were female (83.0%). Complete response was observed in 91.1% (n = 62) of the PEA group and 98.5% (n = 67) of the PTx group. According to repeated-measures analysis, Calcium, PTH, Phosphorus, and Alkaline phosphatase fell significantly and continuously in each intervention group, except for the persistent patients. According to ROC analysis, a cutoff of > 425.5 mm3 for the adenoma volume and > 13.5 mm for its largest diameter showed a sensitivity = 75% and specificity = 69% for partial response in the PEA group (AUC = 0.81 and 0.84, respectively). PTx group experienced statistically significant higher pain according to the Visual Analogue Scale (VAS score) (p < 0.001).

Conclusion: PTH, serum-adjusted Calcium, and adenoma size and volume were all significantly reduced by PTx and PEA, with no significant difference between them. PEA is an effective alternative to PTx, particularly in adenomas with a volume of less than 425.5 mm3 and a maximum diameter of 13.5 mm.

Trial registration number: IRCT20210204050241N1 (04/26/2021).

Keywords: Ablation techniques; Parathyroid adenoma; Parathyroidectomy; Primary hyperparathyroidism.

Fig. 1

CONSORT 2010 flow diagram

Fig. 2

ROC curve analysis to establish a cutoff criterion for the recurrence of hyperparathyroidism following alcohol ablation, based on the volume and maximum diameter of the adenoma. A threshold of > 425.5 mm³ for adenoma volume and > 13.5 mm for its greatest diameter demonstrated a sensitivity of 75% and specificity of 69% for recurrence in the alcohol ablation group (AUC = 0.81 and 0.84, respectively)