Actively Recruiting
Endoscopic Ultrasound-guided Radiofrequency Ablation Compared With Adrenalectomy for Left-sided Primary Aldosteronism and Mild Autonomous Cortisol Secretion
Led by Haukeland University Hospital · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- For all groups, if CT scan shows an adrenal nodule on the same side as AVS lateralisation: nodule size less than 4 cm and enhancement criteria for adrenal adenoma
- PA unilateral group: age 18 to 60 years, PA diagnosis confirmed by Endocrine Society PA Guideline criteria, AVS lateralisation to left adrenal (lateralisation index 2464 4.0)
- PA debulking group: age 18 to 70 years, PA diagnosis confirmed by Endocrine Society PA Guideline criteria
- MACS unilateral and debulking groups: age 18 to 80 years, MACS diagnosis confirmed by ENSAT/ECE Guideline criteria, AVS lateralisation to left adrenal with visible left adrenal tumor on CT scan OR bilateral cortisol overproduction on AVS with bilateral tumors/hyperplasia on CT scan
You will not qualify if you...
- CT scan suspicion of adrenal malignancy
- Patient refusal to undergo either EUS-RFA or adrenalectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including CT scan and AVS
Duration - Single day procedure with 24-hour hospital observation
Participants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of the left adrenal tumour. This includes fasting, prophylactic antibiotics, conscious sedation, EUS-guided fine needle tissue sampling, and the RFA procedure. Participants are observed for a few hours post-procedure and stay in the ward for 24 hours.
1 treatment visit (in-person) including the EUS-RFA procedure and post-procedure observation
Duration - 12 months
Participants are evaluated for clinical and biochemical outcomes, and procedural complications after treatment using international criteria. Follow-up occurs at multiple time points to monitor recovery and treatment effect.
3 follow-up visits at approximately 2 weeks, 3 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
M
Marianne Grytaas, MD phd
R
Roald Havre, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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