Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513585
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Super Selective Adrenal Artery Embolization Versus Adrenalectomy in the Treatment of Unilateral PA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The First Affiliated Hospital of Xinjiang Medical University
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAAE-PA II
Brief 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
Detailed Description:
Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease which leads to increased sodium and potassium discharge increased fluid volume and inhibition of renin-angiotensin-aldosterone system It is one of the common causes of secondary hypertension as clinical symptoms with hypertension hypokalemia hyperaldosterone and low renin It accounts for 5 to 13 of people with hypertension In addition to the impact of hypertension itself on the body the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events and the risk of stroke atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension so early detection and reasonable treatment are crucial PA can be divided into 6 types according to the etiology of which the most common is idiopathic aldosteronism IHA and aldosteronoma accounting for 60 and 30 respectively unilateral adrenal hyperplasia followed the other subtypes are less common Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA while unilateral PA is preferred by surgery and laparoscopic adrenalectomy However surgical treatment also has many limitations First not all patients with surgical indications have the opportunity to undergo adrenal resection Surgical treatment is not suitable for patients with difficult laparoscopic operation such as obesity serious abdominal adhesion due to previous surgical history and high-risk surgery such as cardiovascular and cerebrovascular diseases and emphysema In addition adrenal resection may lead to adrenal dysfunction serious infection retroperitoneal hematoma and many other adverse reactions The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria and to conduct a prospective multicenter randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None