Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
NCT ID: NCT05991856
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2020-01-01
2030-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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radiofrequency ablation
Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
radiofrequency 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.
Hypotensive Drugs
All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.
laparoscopic adrenalectomy
Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
laparoscopic 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.
Hypotensive Drugs
All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.
Interventions
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radiofrequency 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.
laparoscopic 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.
Hypotensive Drugs
All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Xubin Yang
Dr.
Principal Investigators
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Mengyin Cai, Dr
Role: STUDY_CHAIR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Funder 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.
Brown 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.
Williams 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.
Yang 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.
Other Identifiers
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HuanXu
Identifier Type: -
Identifier Source: org_study_id
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