Hyperaldosteronism Clinical Trial
— LARFAOfficial title:
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
Verified date | April 2017 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Liu SY, Ng EK, Lee PS, Wong SK, Chiu PW, Mui WL, So WY, Chow FC. Radiofrequency ablation for benign aldosterone-producing adenoma: a scarless technique to an old disease. Ann Surg. 2010 Dec;252(6):1058-64. doi: 10.1097/SLA.0b013e318f66936. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity rate | 30-day | ||
Primary | Resolution of hyperaldosteronism | 1 year | ||
Secondary | Operative time | 24 hours | ||
Secondary | Periprocedural hypertensive crisis | 24 hours | ||
Secondary | Mortality rate | 30 days | ||
Secondary | Blood loss | 24 hours | ||
Secondary | Analgesic requirement | 30 days | ||
Secondary | Time to resumption of activity | 30 days | ||
Secondary | Resolution of hypokalaemia | 1 year | ||
Secondary | Blood pressure control | 1 year | ||
Secondary | Hospital stay | 30 days | ||
Secondary | Pain score | 7 days |
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