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

Inclusion Criteria5

  • 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 ≥ 18;
  • 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 Criteria7

  • 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.

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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