NCT07470580

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

Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%. More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma. Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.

Detailed description

Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of PA. Medical therapy or adrenalectomy are the 2 options to be considered. Laparoscopic adrenalectomy (LA) has been reported to be cost-effective compared with lifelong oral administration alone in unilateral PA. Therefore, LA is the gold standard for unilateral PA to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of BP control with an overall complication rate of 5 to 14%. More recently, radiofrequency ablation (RFA) has been used for patients with APA with an hormonal success obtained in 92% of patients treated by umbrella-shaped needle . RFA for hypertensive patients with APA seems to be an emerging promising alternative to surgery. . Investigator team anticipate that radiofrequency allows a hormonal success of the same order than with adrenalectomy (around 95%), with simpler follow-up than surgery. The main objective of the study is to test the non-inferiority of radiofrequency ablation compared to adrenalectomy, among hypertensive patients with primary aldosteronism and unilateral adrenal adenoma in order to normalize hormonal endpoints at 3 months of follow-up. Cost-effectiveness and cost-utility analysis will be conducted to assess the efficiency of radiofrequency in the frame of the project.

Conditions

• Primary Aldosteronism Due to Conn Adenoma
• Radiofrequency Ablation Treatment
• Adrenalectomy

Interventions

Type	Name	Description
PROCEDURE	RFA -radiofrequency ablation	Under real-time multidetector CT-guidance, the patients will be put in either prone or lateral decubitus position to choose for the optimal access route for RFA needle electrode. Under multidetector CT guidance, patients would be treated with regard to optimal RFA needle access route with a hydrodissection or aero dissection if necessary. 2 types of generator (Boston Scientific RF 3000, and Ablatech Amica) and of needle electrodes (Leveen-type extendable, Ablatech) will be used according to the routine care of the centers
PROCEDURE	Adrenalectomy	Adrenalectomy may be performed using a laparoscopic or open approach. In either approach, the gland may be approached transabdominally or retroperitoneally. The choice of surgical approach depends on the size and nature of the lesion, the patient's general characteristics and the expertise of the surgeon. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: France