NCT05991856

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

Resident Doctor, Master Degree Candidate

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary aldosteronism is the most common cause of secondary hypertension, and aldosterone-producing adenoma (APA) is a benign adrenal tumor, accounting for about 35% of primary aldosteronism. According to clinical guidelines, laparoscopic adrenalectomy is the preferred treatment for unilateral APA. Recently, radiofrequency ablation, as a new technique, has been applied to the treatment of APA. However, there are few relevant studies, the sample size is generally small, and basically belong to retrospective studies, lacking the comparison of long-term postoperative effects. Our hospital is the first to carry out ultrasound-guided radiofrequency ablation of APA in Guangdong, China, with satisfactory results. The purpose of this study is to retrospectively and prospectively analyze the efficacy and safety of ultrasound guided radiofrequency elimination and laparoscopic adrenalectomy in the treatment of 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.

Conditions

• Aldosterone-producing Adenoma
• Radiofrequency Ablation

Interventions

Type	Name	Description
PROCEDURE	radiofrequency 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.
PROCEDURE	laparoscopic 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.
DRUG	Hypotensive Drugs	All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-10-01
• Completion: 2030-12-01
• First posted: 2023-08-15
• Last updated: 2023-08-15

Locations

1 site across 1 country: China