Resident Doctor, Master Degree Candidate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Blood pressure
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥ 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
- •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;
- •Imaging showed potential malignant adrenal tumor;
- •Pregnant and/or planning a pregnancy;
- •Refusing to participate in follow-up visits.
Arms & Interventions
radiofrequency ablation
Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
Intervention: radiofrequency ablation (Procedure)
radiofrequency ablation
Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
Intervention: Hypotensive Drugs (Drug)
laparoscopic adrenalectomy
Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
Intervention: laparoscopic adrenalectomy (Procedure)
laparoscopic adrenalectomy
Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
Intervention: Hypotensive Drugs (Drug)
Outcomes
Primary Outcomes
Blood pressure
Time Frame: 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
Time Frame: Within 3 years
Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.
ARR
Time Frame: 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
Time Frame: Within 3 years
Intraoperative or postoperative complications of both types of surgery, including hypertensive crises, bleeding, and pancreatitis.
PASO
Time Frame: 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
Time Frame: Within 3 years
The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.
Secondary Outcomes
- Operation cost(Within 3 years)
- Length of hospital stays(Within 3 years)
Investigators
Xubin Yang
Dr.
Third Affiliated Hospital, Sun Yat-Sen University