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

NCT05991856 | Recruiting

• 1 other identifier: HuanXu
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aldosterone-producing Adenoma; Radiofrequency Ablation

Keywords

aldosterone-producing adenoma; radiofrequency ablation; laparoscopic adrenalectomy

Outcome Measures

Primary Outcomes (6)

• Blood pressure

  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).

  Within 3 years

• Serum potassium

  Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.

  Within 3 years

• Aldosterone

  The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.

  Within 3 years

• ARR

  The effects of radiofrequency ablation and laparoscopic adrenalectomy on ARR (plasma aldosterone to renin activity ratio) in aldosterone-producing adenoma patients.

  Within 3 years

• Complications

  Intraoperative or postoperative complications of both types of surgery, including hypertensive crises, bleeding, and pancreatitis.

  Within 3 years

• PASO

  PASO(the Primary Aldosteronism Surgical Outcome) criteria were used to standardize the evaluation of outcomes of radiofrequency ablation and laparoscopic adrenalectomy, divided into clinical and biochemical outcomes, and the outcome grades were defined in terms of complete success, partial success, and unsuccessful.

  Within 3 years

Secondary Outcomes (2)

• Operation cost

  Within 3 years

• Length of hospital stays

  Within 3 years

Study Arms (2)

radiofrequency ablation

Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation

Procedure: radiofrequency ablation; Drug: Hypotensive Drugs

laparoscopic adrenalectomy

Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy

Procedure: laparoscopic adrenalectomy; Drug: Hypotensive Drugs

Interventions

radiofrequency ablation PROCEDURE

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.

Also known as: RFA

radiofrequency ablation

laparoscopic adrenalectomy PROCEDURE

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.

Also known as: LA

laparoscopic adrenalectomy

Hypotensive Drugs DRUG

All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.

Also known as: HD

laparoscopic adrenalectomy; radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From January 2020 to January 2024, patients with APA were treated with adrenal RFA in our hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 32449886 BACKGROUND

• 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.

  PMID: 28576687 BACKGROUND

• 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.

  PMID: 27300650 BACKGROUND

MeSH Terms

Conditions

Adrenocortical Adenoma

Interventions

Radiofrequency Ablation; Antihypertensive Agents

Condition Hierarchy (Ancestors)

Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mengyin Cai, Dr

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Xubin Yang, Dr

CONTACT

13763336436; yxbin@mail.sysu.edu.cn

Huan Xu, Dr

CONTACT

15218969361; huanhey@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 15, 2023
• Study Start: January 1, 2020
• Primary Completion: October 1, 2024
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)