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/26934393Actively Recruiting
Age: 18Years +
All Genders
ID05991856
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2023-08-15
45
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed unilateral aldosterone-producing adenoma (APA)
- Benign tumor without adrenal metastasis or vascular tumor embolus
- Undergoing ultrasound-guided adrenal radiofrequency ablation or laparoscopic adrenalectomy
- Signed informed consent for surgery
- Age 18 years or older
- For participants aged 40 and above: blood potassium 6le; 3.5 mmol/L; plasma aldosterone concentration 6ge; 20 ng/dL; plasma renin concentration 6le; 5 bcIU/mL; unilateral adrenal nodule 10 mm or larger; opposite adrenal gland normal
You will not qualify if you...
- Bilateral adrenal diseases
- Multiple adrenal tumors
- Other adrenal diseases such as adrenal hyperplasia, Cushing's syndrome, pheochromocytoma
- Tumor difficult to reach based on imaging
- Potential malignant adrenal tumor on imaging
- Pregnant or planning pregnancy
- Refusal to participate in follow-up visits
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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)
Post-operative Follow-up
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
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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Research Team
X
Xubin Yang, Dr
H
Huan Xu, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study.
Jenifer M Brown, Mohammed Siddiqui, David A Calhoun...
https://pubmed.ncbi.nlm.nih.gov/32449886Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort.
Tracy A Williams, Jacques W M Lenders, Paolo Mulatero...
https://pubmed.ncbi.nlm.nih.gov/28576687Comparison of radiofrequency ablation versus laparoscopic adrenalectomy for benign aldosterone-producing adenoma.
Min-Hsin Yang, Yeu-Sheng Tyan, Yu-Hui Huang...
https://pubmed.ncbi.nlm.nih.gov/27300650