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Trial Title:
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma
NCT ID:
NCT05991856
Condition:
Aldosterone-producing Adenoma
Radiofrequency Ablation
Conditions: Official terms:
Adenoma
Adrenocortical Adenoma
Antihypertensive Agents
Conditions: Keywords:
aldosterone-producing adenoma
radiofrequency ablation
laparoscopic adrenalectomy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
radiofrequency ablation
Description:
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.
Arm group label:
radiofrequency ablation
Other name:
RFA
Intervention type:
Procedure
Intervention name:
laparoscopic adrenalectomy
Description:
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.
Arm group label:
laparoscopic adrenalectomy
Other name:
LA
Intervention type:
Drug
Intervention name:
Hypotensive Drugs
Description:
All subjects in the study selected appropriate antihypertensive drugs based on factors
such as blood pressure level.
Arm group label:
laparoscopic adrenalectomy
Arm group label:
radiofrequency ablation
Other name:
HD
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
From January 2020 to January 2024, patients with APA were treated with adrenal RFA in our
hospital
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Huan Xu, Dr.
Phone:
15218969361
Email:
huanhey@126.com
Contact backup:
Last name:
Xubin Yang, Dr.
Phone:
13763336436
Email:
yxbin@mail.sysu.edu.cn
Start date:
January 1, 2020
Completion date:
December 1, 2030
Lead sponsor:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
Third Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991856
