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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • radiofrequency ablation

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Drug

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

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: radiofrequency ablation2 interventions
Group B: laparoscopic adrenalectomy2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Within 3 years
2

Serum potassium

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

Time frame
Within 3 years
3

Aldosterone

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

Time frame
Within 3 years
4

ARR

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

Time frame
Within 3 years

Secondary outcomes

1

Operation cost

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

Time frame
Within 3 years
2

Length of hospital stays

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

Time frame
Within 3 years

Other outcomes

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