Status:
RECRUITING
Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Lead Sponsor:
Haukeland University Hospital
Conditions:
Primary Aldosteronism
Aldosterone-Producing Adenoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in ...
Detailed Description
Primary aldosteronism (PA) is the most common cause of secondary hypertension, and is associated with worse cardiovascular outcome than primary hypertension. Early diagnosis and treatment is paramount...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05368090
Start Date
June 3 2022
End Date
December 31 2028
Last Update
November 8 2024
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Norway, 5021