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

Recruiting

• Conditions: Aldosterone-producing Adenoma; Radiofrequency Ablation
• Interventions: Procedure: radiofrequency ablation; Procedure: laparoscopic adrenalectomy; Drug: Hypotensive Drugs

• Registration Number: NCT05991856
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-07-23
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-13
• Last Update Submitted: 2023-08-13
• Study First Posted: 2023-08-15
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-10-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic adrenalectomy	Hypotensive Drugs	Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
radiofrequency ablation	radiofrequency ablation	Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
radiofrequency ablation	Hypotensive Drugs	Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
laparoscopic adrenalectomy	laparoscopic adrenalectomy	Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy

Primary Outcome Measures

Name	Time	Method
Blood pressure	Within 3 years	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	Within 3 years	Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.
ARR	Within 3 years	The effects of radiofrequency ablation and laparoscopic adrenalectomy on ARR (plasma aldosterone to renin activity ratio) in aldosterone-producing adenoma patients.
Complications	Within 3 years	Intraoperative or postoperative complications of both types of surgery, including hypertensive crises, bleeding, and pancreatitis.
PASO	Within 3 years	PASO(the Primary Aldosteronism Surgical Outcome) criteria were used to standardize the evaluation of outcomes of radiofrequency ablation and laparoscopic adrenalectomy, divided into clinical and biochemical outcomes, and the outcome grades were defined in terms of complete success, partial success, and unsuccessful.
Aldosterone	Within 3 years	The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.

Secondary Outcome Measures

Name	Time	Method
Operation cost	Within 3 years	Comparison of the operation costs of radiofrequency ablation and laparoscopic adrenalectomy.
Length of hospital stays	Within 3 years	Comparison of the hospital stays of radiofrequency ablation and laparoscopic adrenalectomy.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China