Comparing ultrasound-guided ablation and laparoscopic surgery for adrenal tumors
Resident Doctor, Master Degree Candidate
Third Affiliated Hospital, Sun Yat-Sen University · NCT05991856
This study is testing whether ultrasound-guided radiofrequency ablation is as safe and effective as laparoscopic surgery for treating adrenal tumors in patients with aldosterone-producing adenoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05991856 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the efficacy and safety of ultrasound-guided radiofrequency ablation versus laparoscopic adrenalectomy for treating aldosterone-producing adenoma (APA). It will involve a retrospective collection of data from 30 patients who underwent radiofrequency ablation and 15 patients who had laparoscopic adrenalectomy, matched by age and sex. The study will follow these patients for three years to assess long-term outcomes. This research is significant as it is one of the first to compare these two treatment methods in a larger cohort.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed unilateral aldosterone-producing adenoma.
Not a fit: Patients with bilateral adrenal diseases, multiple adrenal tumors, or other adrenal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a less invasive treatment option for patients with aldosterone-producing adenoma.
How similar studies have performed: While there have been few studies on this topic, the approach of using ultrasound-guided radiofrequency ablation is relatively novel and has shown promising results in preliminary cases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Xubin Yang, Dr
- Email: yxbin@mail.sysu.edu.cn
- Phone: 13763336436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aldosterone-producing Adenoma, Radiofrequency Ablation, aldosterone-producing adenoma, radiofrequency ablation, laparoscopic adrenalectomy