Clinical trial · Observational
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
Resident Doctor, Master Degree Candidate
NCT05991856CI-TRIAL-00068828recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aldosterone-producing Adenoma | Adrenal Cortical Adenoma | PROBABILISTIC | 0.70 |
| Radiofrequency Ablation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypotensive Drugs | Drug | — | UNRESOLVED |
| laparoscopic adrenalectomy | Procedure | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- radiofrequency ablation
- description
- Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
- interventionNames
- Procedure: radiofrequency ablation
- Drug: Hypotensive Drugs
- label
- laparoscopic adrenalectomy
- description
- Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
- interventionNames
- Procedure: laparoscopic adrenalectomy
- Drug: Hypotensive Drugs
Primary outcomes (6)
- measure
- Blood pressure
- timeFrame
- Within 3 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDFunder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. PMID 26934393
- BACKGROUNDBrown JM, Siddiqui M, Calhoun DA, Carey RM, Hopkins PN, Williams GH, Vaidya A. The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study. Ann Intern Med. 2020 Jul 7;173(1):10-20. doi: 10.7326/M20-0065. Epub 2020 May 26. PMID 32449886
- BACKGROUNDWilliams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30. PMID 28576687
- BACKGROUNDYang MH, Tyan YS, Huang YH, Wang SC, Chen SL. Comparison of radiofrequency ablation versus laparoscopic adrenalectomy for benign aldosterone-producing adenoma. Radiol Med. 2016 Oct;121(10):811-9. doi: 10.1007/s11547-016-0662-1. Epub 2016 Jun 14. PMID 27300650