Laparoscopic Adrenalectomy Versus Radiofrequency Ablation (LARFA)

The Chinese University of Hong Kong

Status: Unknown

Conditions: Conn Syndrome; Hyperaldosteronism; Adrenocortical Adenoma

Treatments: Procedure: Radiofrequency Ablation; Procedure: Laparoscopic Adrenalectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02030587

CRE-2012.193-T

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Radiofrequency Ablation

Experimental group

Description:

Radiofrequency Ablation

Treatment:

Procedure: Radiofrequency Ablation

Laparoscopic Adrenalectomy

Active Comparator group

Description:

Laparoscopic Adrenalectomy

Treatment:

Procedure: Laparoscopic Adrenalectomy