Comparing Radiofrequency Ablation and Adrenalectomy for Treating Unilateral Adenoma in Adults with Primary Aldosteronism and High Blood Pressure

What this Trial Is About

Primary aldosteronism is a condition marked by high blood pressure, frequent low potassium levels, and an abnormal aldosterone-to-renin ratio. One main cause is aldosterone-producing adenoma, also known as Conn syndrome. This trial compares two treatments for patients with this condition and a unilateral adrenal adenoma radiofrequency ablation RFA and laparoscopic adrenalectomy LA, which is currently the standard surgical approach. The study aims to evaluate whether RFA is as effective as adrenalectomy in normalizing hormone levels and controlling blood pressure. Participants will receive either RFA using needle electrodes guided by real-time CT imaging, or undergo adrenalectomy via laparoscopic or open surgery. The choice of surgical method depends on the lesion and patient factors. RFA is a newer approach that may offer similar hormonal success with fewer complications and simpler follow-up. The study will assess clinical and hormonal outcomes, as well as cost-effectiveness, with follow-up visits up to 6 months after treatment. Throughout the study, participants will be monitored with hormone tests, blood pressure measurements, and evaluation of potassium levels to assess treatment success. Safety and adverse events will also be recorded. The primary outcome is the aldosterone-to-renin ratio measured at 3 months post-treatment. Secondary outcomes include clinical success at various time points, correction of hypokalemia, changes in blood pressure, medication use, and length of hospital stay. Participants are expected to be followed for up to 6 months after intervention.

Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension