Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

Not Applicable

• Conditions: Hyperaldosteronism; Conn Syndrome; Adrenocortical Adenoma
• Interventions: Procedure: Radiofrequency Ablation; Procedure: Laparoscopic Adrenalectomy

• Registration Number: NCT02030587
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-05
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-22
• Last Update Posted: 2017-04-25
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Hypertensive individuals
2. Biochemically confirmed primary aldosteronism
3. Radiologically confirmed unilateral adrenal adenoma ≤3cm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation	Radiofrequency Ablation	Radiofrequency Ablation
Laparoscopic Adrenalectomy	Laparoscopic Adrenalectomy	Laparoscopic Adrenalectomy

Primary Outcome Measures

Name	Time	Method
Morbidity rate	30-day
Resolution of hyperaldosteronism	1 year

Secondary Outcome Measures

Name	Time	Method
Time to resumption of activity	30 days
Periprocedural hypertensive crisis	24 hours
Analgesic requirement	30 days
Operative time	24 hours
Hospital stay	30 days
Mortality rate	30 days
Blood loss	24 hours
Resolution of hypokalaemia	1 year
Blood pressure control	1 year
Pain score	7 days

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong