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NCT02030587 Clinical Trial

Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

Hyperaldosteronism Clinical Trial

— LARFA  

Official title:
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02030587
Other study ID # CRE-2012.193-T
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 5, 2014
Last updated April 22, 2017
Start date January 2013
Est. completion date December 2017

Study information
Verified date April 2017
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiofrequency Ablation

• Laparoscopic Adrenalectomy

Locations
Country Name City State
Hong Kong Prince of Wales Hospital Shatin

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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

Outcome
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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