The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.
John W Funder, Robert M Carey, Franco Mantero...
https://pubmed.ncbi.nlm.nih.gov/26934393/Actively Recruiting
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2023-08-15
45
Participants Needed
1
Research Sites
321 weeks
Total Duration
Primary aldosteronism, a common cause of secondary hypertension, is often due to aldosterone-producing adenoma APA, a benign adrenal tumor. This research aims to compare the safety and effectiveness of two treatments for APA ultrasound-guided radiofrequency ablation and laparoscopic adrenalectomy. The study will include both retrospective and prospective analysis to better understand long-term outcomes, as previous studies have been limited and mostly retrospective. The study involves two groups of patients with APA one treated with ultrasound-guided radiofrequency ablation where electrodes deliver radiofrequency current to destroy adrenal nodules under local anesthesia, and the other treated with laparoscopic adrenalectomy, a surgical removal of the adrenal gland performed under general anesthesia. The study will collect data from patients treated between January 2020 and June 2024, including 30 patients who had radiofrequency ablation and 15 matched patients who had laparoscopic adrenalectomy, with follow-up planned for 3 years. Participants will be monitored for changes in blood pressure, serum potassium, aldosterone, aldosterone-to-renin ratio ARR, complications, and clinical outcomes over three years. Additional assessments include operation costs and length of hospital stays. The study involves regular follow-up visits to evaluate these outcomes and ensure safety. The total participation duration for patients is up to 3 years after treatment to assess long-term effects.
CONDITIONS
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
X
Xubin Yang, Dr
H
Huan Xu, Dr
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Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants undergo either ultrasound-guided radiofrequency ablation or laparoscopic adrenalectomy as the treatment for aldosterone-producing adenoma.
1 procedure visit (in-person)
Duration - Up to 3 years
Participants are followed to monitor blood pressure, serum potassium, aldosterone levels, complications, and other outcomes after treatment.
Follow-up visits over 3 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/32449886/Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor