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

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Aug 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a condition called aldosterone-producing adenoma (APA), which is a type of benign tumor in the adrenal gland that can affect hormone levels. Researchers want to compare the safety and effectiveness of ultrasound-guided radiofrequency ablation (a minimally invasive procedure that uses heat to destroy the tumor) with laparoscopic adrenalectomy (a surgical procedure to remove the tumor). The study will include 30 patients who undergo radiofrequency ablation and 15 who have laparoscopic surgery, all conducted at the same hospital from January 2020 to June 2024. Participants will be followed for three years to see how well each treatment works.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of a single, benign adrenal tumor. They should not have any other adrenal diseases or multiple tumors and must be willing to sign a consent form for the treatment. The trial is currently seeking participants of all genders aged 40 and older who meet specific health criteria related to their hormone levels. If you decide to participate, you can expect regular check-ups and monitoring over the duration of the study to assess your health and the treatment outcomes.

Gender

ALL

Eligibility criteria

• 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.