RecruitingNCT05991856

Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma

Resident Doctor, Master Degree Candidate


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

45 participants

Start Date

Jan 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for a type of benign adrenal gland tumor that causes high blood pressure and low potassium: ultrasound-guided heat ablation (destroying the tumor with heat using a probe) versus surgical removal through small incisions (laparoscopic surgery). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with an aldosterone-producing adenoma (a non-cancerous adrenal gland tumor) on one side only - The tumor is confirmed benign with no spread - You are scheduled for either ultrasound-guided ablation or laparoscopic surgery **You may NOT be eligible if...** - Your tumor is on both adrenal glands - There is any concern of cancer or blood vessel involvement - You do not meet specific blood test criteria (for patients 40 years and older) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREradiofrequency ablation

The 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.

PROCEDURElaparoscopic adrenalectomy

The 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.

DRUGHypotensive Drugs

All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.


Locations(1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05991856


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