Adrenocortical Adenoma, Conn Syndrome, Hyperaldosteronism
Conditions
Keywords
Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation
Brief summary
This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA) versus image-guided percutaneous radiofrequency ablation (RFA) in treating aldosterone-producing adenoma. The objectives of this study are to 1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma. 2. compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.
Interventions
PROCEDURERadiofrequency Ablation
PROCEDURELaparoscopic Adrenalectomy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Hypertensive individuals 2. Biochemically confirmed primary aldosteronism 3. Radiologically confirmed unilateral adrenal adenoma ≤3cm
Exclusion criteria
1. Bilateral adrenal disease 2. Multiple adrenal tumors 3. Other concomitant adrenal diseases 4. Potentially malignant adrenal tumors as shown on imaging 5. Uncorrected coagulopathy 6. Surgically unfit for general anaesthesia 7. Prior open abdominal surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbidity rate | 30-day |
| Resolution of hyperaldosteronism | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate | 30 days |
| Blood loss | 24 hours |
| Analgesic requirement | 30 days |
| Time to resumption of activity | 30 days |
| Operative time | 24 hours |
| Blood pressure control | 1 year |
| Hospital stay | 30 days |
| Pain score | 7 days |
| Resolution of hypokalaemia | 1 year |
| Periprocedural hypertensive crisis | 24 hours |
Countries
Hong Kong
Outcome results
None listed