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NCT Number: NCT05991856

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Primary aldosteronism is the most common cause of secondary hypertension, and aldosterone-producing adenoma (APA) is a benign adrenal tumor, accounting for about 35% of primary aldosteronism. According to clinical guidelines, laparoscopic adrenalectomy is the preferred treatment for unilateral APA. Recently, radiofrequency ablation, as a new technique, has been applied to the treatment of APA. However, there are few relevant studies, the sample size is generally small, and basically belong to retrospective studies, lacking the comparison of long-term postoperative effects. Our hospital is the first to carry out ultrasound-guided radiofrequency ablation of APA in Guangdong, China, with satisfactory results. The purpose of this study is to retrospectively and prospectively analyze the efficacy and safety of ultrasound guided radiofrequency elimination and laparoscopic adrenalectomy in the treatment of 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: RFA

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.

Other names: LA

Hypotensive Drugs

Drug

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

Other names: HD

Primary outcomes

  1. Blood pressure

    Time frame: Within 3 years

    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).

  2. Serum potassium

    Time frame: Within 3 years

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

  3. Aldosterone

    Time frame: Within 3 years

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

  4. ARR

    Time frame: Within 3 years

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

  5. Complications

    Time frame: Within 3 years

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

  6. PASO

    Time frame: Within 3 years

    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.

Secondary outcomes

  1. Operation cost

    Time frame: Within 3 years

    Comparison of the operation costs of radiofrequency ablation and laparoscopic adrenalectomy.

  2. Length of hospital stays

    Time frame: Within 3 years

    Comparison of the hospital stays of radiofrequency ablation and laparoscopic adrenalectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Huan Xu, Dr

CONTACT

[email protected]

15218969361

Xubin Yang, Dr

CONTACT

[email protected]

13763336436

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Resident Doctor, Master Degree Candidate

Important dates

Study start
2020
Primary completion
2024
Study completion
2030
First posted
Aug 15, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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