Actively Recruiting
Endoscopic Ultrasound-Guided Radiofrequency Ablation for Left-Sided Primary Aldosteronism and Mild Autonomous Cortisol Secretion Compared With Adrenalectomy
Led by Haukeland University Hospital · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating endoscopic ultrasound-guided radiofrequency ablation EUS-RFA as a treatment for left-sided adrenal tumors in patients with primary aldosteronism PA and mild autonomous cortisol secretion MACS. The study aims to compare clinical and biochemical outcomes, as well as procedural safety, of EUS-RFA with conventional unilateral adrenalectomy. Four patient groups are included based on their specific hormone overproduction and tumor characteristics. All participants will undergo EUS-RFA targeting the left adrenal tumor. The procedure involves fasting, sedation, and the use of an echo-endoscope to locate and ablate the tumor using a water-cooled radiofrequency catheter. Fine needle tissue sampling is performed before ablation for detailed analysis. Participants are monitored post-procedure for a few hours and may stay in the ward for 24 hours. Follow-up visits occur at 2 weeks, 3 months, and 12 months to assess outcomes and safety. Participants will have clinical and biochemical evaluations based on international criteria for PA and MACS during follow-up. Outcomes include hormone levels, clinical improvements, and any procedural complications. The study also compares outcomes with those who undergo standard adrenalectomy. Safety monitoring includes checking for hormone deficiencies after treatment and quality of life changes. The total participation duration is at least one year with multiple follow-up assessments.
CONDITIONS
Brief Title
Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Research Team
M
Marianne Grytaas, MD phd
R
Roald Havre, MD PhD
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