About this trial
The purpose of this study is to retrospectively and prospectively analyze the efficacy and safety of ultrasound-guided radiofrequency ablation and laparoscopic adrenalectomy in the treatment of aldosterone-producing adenoma (APA). It is planned to retrospectively collect 30 patients with adrenal radiofrequency ablation for APA and 15 patients with age - and sex-matched laparoscopic adrenalectomy for APA in our hospital from January 2020 to June 2024, and continue to follow up for 3 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
APA was confirmed with unilateral lesions;
Benign tumor without adrenal metastasis and endovascular tumor embolus;
Receive ultrasound-guided adrenal RFA treatment or laparoscopic resection, and sign the informed consent for surgery;
Age ≥ 18;
Disqualifiers
Bilateral adrenal diseases;
Multiple adrenal tumors;
Other adrenal diseases, such as adrenal hyperplasia, Cushing's syndrome, pheochromocytoma, etc.;
Imaging suggests that the tumor may be difficult to reach;
Trial population
From January 2020 to January 2024, patients with APA were treated with adrenal RFA in our hospital
Trial design
Cohort
Other
Treatments tested in this trial
radiofrequency ablation
Procedure/SurgeryThe subjects is placed in a prone or lateral position under local anesthesia, and the electrodes are placed in the adrenal nodules under ultrasound guidance. A rapidly alternating radiofrequency current (300-500khz) generated around the electrode propagates through the adrenal nodules, causing resistance heating (Joule effect) and inducing cell death through coagulation necrosis. The choice of ablation time and frequency depends on the size, shape and location of the nodules within the adrenal gland.
laparoscopic adrenalectomy
Procedure/SurgeryThe subjects was placed in a lateral position under general anesthesia. Using harmonic scalpel carefully separates the adrenal vessels and lates them. The adipose tissue around the adrenal gland is dissected carefully, the surrounding tissue is bluntly separated, and the adrenal gland is fully exposed and dissected. After adrenalectomy was completed, hemostasis was rechecked and specimens were removed.
Hypotensive Drugs
DrugAll subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.
Treatment groups
Trial outcomes
Primary outcomes
Blood pressure
Effect of radiofrequency ablation and laparoscopic adrenalectomy on blood pressure levels in aldosterone-producing adenoma patients, including systolic and diastolic blood pressure(in millimeters of mercury, mmHg).
Serum potassium
Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.
Aldosterone
The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.
ARR
The effects of radiofrequency ablation and laparoscopic adrenalectomy on ARR (plasma aldosterone to renin activity ratio) in aldosterone-producing adenoma patients.
Secondary outcomes
Operation cost
Comparison of the operation costs of radiofrequency ablation and laparoscopic adrenalectomy.
Length of hospital stays
Comparison of the hospital stays of radiofrequency ablation and laparoscopic adrenalectomy.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.