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Laparoscopic Adrenalectomy Versus Radiofrequency Ablation (LARFA)

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ClinicalTrials.gov Identifier: NCT02030587
Recruitment Status : Unknown
Verified April 2017 by Enders K.W. Ng, Chinese University of Hong Kong.
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Enders K.W. Ng, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperaldosteronism Conn Syndrome Adrenocortical Adenoma Procedure: Radiofrequency Ablation Procedure: Laparoscopic Adrenalectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiofrequency Ablation
Radiofrequency Ablation
 Procedure: Radiofrequency Ablation
Active Comparator: Laparoscopic Adrenalectomy
Laparoscopic Adrenalectomy
 Procedure: Laparoscopic Adrenalectomy


Outcome Measures
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Primary Outcome Measures :
  1. Morbidity rate [ Time Frame: 30-day ]
  2. Resolution of hyperaldosteronism [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: 24 hours ]
  2. Periprocedural hypertensive crisis [ Time Frame: 24 hours ]
  3. Mortality rate [ Time Frame: 30 days ]
  4. Blood loss [ Time Frame: 24 hours ]
  5. Analgesic requirement [ Time Frame: 30 days ]
  6. Time to resumption of activity [ Time Frame: 30 days ]
  7. Resolution of hypokalaemia [ Time Frame: 1 year ]
  8. Blood pressure control [ Time Frame: 1 year ]
  9. Hospital stay [ Time Frame: 30 days ]
  10. Pain score [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030587


Locations
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Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Study Chair: Enders KW Ng, MB ChB Chinese University of Hong Kong
Principal Investigator: Shirley YW Liu, MB ChB Chinese University of Hong Kong
More Information
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Publications:

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Responsible Party: Enders K.W. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02030587    
Other Study ID Numbers: CRE-2012.193-T
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Enders K.W. Ng, Chinese University of Hong Kong:
Hyperaldosteronism
Adrenocortical adenoma
Adrenalectomy
Catheter ablation
Additional relevant MeSH terms:
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Adenoma
Adrenocortical Adenoma
Hyperaldosteronism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
 Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases