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Laparoscopic Adrenalectomy Versus Radiofrequency Ablation (LARFA)

Primary Purpose

Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Radiofrequency Ablation
Laparoscopic Adrenalectomy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperaldosteronism focused on measuring Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiofrequency Ablation

Laparoscopic Adrenalectomy

Arm Description

Radiofrequency Ablation

Laparoscopic Adrenalectomy

Outcomes

Primary Outcome Measures

Morbidity rate
Resolution of hyperaldosteronism

Secondary Outcome Measures

Operative time
Periprocedural hypertensive crisis
Mortality rate
Blood loss
Analgesic requirement
Time to resumption of activity
Resolution of hypokalaemia
Blood pressure control
Hospital stay
Pain score

Full Information

First Posted
January 5, 2014
Last Updated
April 22, 2017
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02030587
Brief Title
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation
Acronym
LARFA
Official Title
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma. compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma
Keywords
Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency Ablation
Arm Type
Experimental
Arm Description
Radiofrequency Ablation
Arm Title
Laparoscopic Adrenalectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic Adrenalectomy
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Adrenalectomy
Primary Outcome Measure Information:
Title
Morbidity rate
Time Frame
30-day
Title
Resolution of hyperaldosteronism
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
24 hours
Title
Periprocedural hypertensive crisis
Time Frame
24 hours
Title
Mortality rate
Time Frame
30 days
Title
Blood loss
Time Frame
24 hours
Title
Analgesic requirement
Time Frame
30 days
Title
Time to resumption of activity
Time Frame
30 days
Title
Resolution of hypokalaemia
Time Frame
1 year
Title
Blood pressure control
Time Frame
1 year
Title
Hospital stay
Time Frame
30 days
Title
Pain score
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertensive individuals Biochemically confirmed primary aldosteronism Radiologically confirmed unilateral adrenal adenoma ≤3cm Exclusion Criteria: Bilateral adrenal disease Multiple adrenal tumors Other concomitant adrenal diseases Potentially malignant adrenal tumors as shown on imaging Uncorrected coagulopathy Surgically unfit for general anaesthesia Prior open abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enders KW Ng, MB ChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shirley YW Liu, MB ChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
21107117
Citation
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.
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Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

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