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

Sun Yat-sen University

Status: Enrolling

Conditions: Radiofrequency Ablation; Aldosterone-producing Adenoma

Treatments: Procedure: radiofrequency ablation; Procedure: laparoscopic adrenalectomy; Drug: Hypotensive Drugs

Study type: Observational

Funder types: Other

Identifiers

NCT05991856

HuanXu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. APA was confirmed with unilateral lesions;
2. Benign tumor without adrenal metastasis and endovascular tumor embolus;
3. Receive ultrasound-guided adrenal RFA treatment or laparoscopic resection, and sign the informed consent for surgery;
4. Age ≥ 18;
5. Age ≥ 40 years old should meet the following criteria: blood potassium ≤3.5mmol/L; PAC≥20ng/dL; PRC≤5μIU/mL; A unilateral adrenal nodule of 10mm or more was completely normal on the opposite side.

Exclusion criteria

1. Bilateral adrenal diseases;
2. Multiple adrenal tumors;
3. Other adrenal diseases, such as adrenal hyperplasia, Cushing's syndrome, pheochromocytoma, etc.;
4. Imaging suggests that the tumor may be difficult to reach;
5. Imaging showed potential malignant adrenal tumor;
6. Pregnant and/or planning a pregnancy;
7. Refusing to participate in follow-up visits.

Trial design

45 participants in 2 patient groups

radiofrequency ablation

Description:

Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation

Treatment:

Drug: Hypotensive Drugs

Procedure: radiofrequency ablation

laparoscopic adrenalectomy

Description:

Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy

Treatment:

Drug: Hypotensive Drugs

Procedure: laparoscopic adrenalectomy