Endoscopic ultrasound-guided radiofrequency ablation for adrenal tumors in primary aldosteronism
Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism
This study is testing a new non-surgical treatment using ultrasound to see if it can help people with primary aldosteronism and adrenal tumors feel better compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen) |
| Trial ID | NCT05368090 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) to treat left-sided adrenal tumors in patients with primary aldosteronism and mild autonomous cortisol secretion. Participants will be divided into groups based on their specific conditions and the presence of adrenal tumors, with outcomes evaluated against control groups undergoing traditional adrenalectomy. The study aims to assess both clinical and biochemical outcomes, as well as the safety of the EUS-RFA procedure. By targeting adrenal tumors non-invasively, the study seeks to provide an alternative treatment option for patients who may not qualify for surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with confirmed primary aldosteronism or mild autonomous cortisol secretion and specific adrenal tumor characteristics.
Not a fit: Patients with bilateral adrenal overproduction or those who do not meet the inclusion criteria for the study may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option for patients with primary aldosteronism, potentially reducing complications associated with traditional surgery.
How similar studies have performed: While the use of EUS-RFA is a novel approach in this context, similar techniques have shown promise in treating other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria all groups * Signed written informed consent * If CT scan shows an adrenal nodule to the same adrenal as AVS lateralisation result: nodule size \< 4 cm and enhancement criteria for adrenal adenoma (native hounsfield units \< 10 or relative wash-out \> 40% or absolute wash-out \> 60%) PA unilateral group inclusion criteria: * Age 18 to 60 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria * AVS lateralisation to left adrenal (lateralisation index ≥ 4,0) PA "debulking" group inclusion criteria: * Age 18 to 70 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria MACS unilateral and debulking group inclusion criteria: * Age 18 to 80 years * MACS diagnosis confirmed according to ENSAT/ECE Guideline criteria * AVS lateralisation to the left adrenal, and visible left adrenal tumor on CT scan OR bilateral overproduction of cortisol on AVS, and bilateral tumors/hyperplasia on CT scan (debulking) Exclusion Criteria all groups: * CT scan suspicion of adrenal malignancy * Patient refusal to undergo either EUS-RFA or adrenalectomy
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Principal investigator: Marianne Grytaas, MD phd — Haukeland University Hospital
- Study coordinator: Marianne Grytaas, MD phd
- Email: marianne.grytaas@helse-bergen.no
- Phone: 004741545435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.