RecruitingNot ApplicableNCT06513585
Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy
The First Affiliated Hospital of Xinjiang Medical University
Sponsor
Xinjiang Medical University
Enrollment
570 participants
Start Date
Aug 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria4
- Age 18-60
- Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
- Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
- Patients and their family members signed informed consent and agreed to participate in the study
Exclusion Criteria10
- A history of severe hypersensitivity to contrast media
- Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
- Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2)
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
- Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
- Stroke, myocardial infarction and stent implantation occurred in the past 3 months
- Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
- Participated in other clinical trials within the past 3 months
- Pregnant, breastfeeding, or planning a pregnancy
- Identify patients with alcohol allergy
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Interventions
PROCEDURESuperselective adrenal artery embolization or adrenalectomy
Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06513585
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