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Laparoscopic Adrenalectomy Versus Radiofrequency Ablation (LARFA)

The Chinese University of Hong Kong logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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