HyperaldosteronismLARFANCT02030587

Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

A study testing Radiofrequency Ablation and Laparoscopic Adrenalectomy in people with Hyperaldosteronism and Conn Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma
What is being tested?: Radiofrequency Ablation and Laparoscopic Adrenalectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteHong Kong
Study dates: Jan 2013to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Prince of Wales Hospital
Shatin

Other trials in Hong Kong

About this study

Official title: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial

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.

Conditions: Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma
Being tested: Radiofrequency Ablation, Laparoscopic Adrenalectomy
Keywords: Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation
Medical subject headings: Hyperaldosteronism, Adrenocortical Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency AblationProcedure or surgery
Laparoscopic AdrenalectomyProcedure or surgery

Study groups in NCT02030587
Study group	Role	What they receive
Radiofrequency Ablation	Experimental	Radiofrequency Ablation Receives: Procedure: Radiofrequency Ablation
Laparoscopic Adrenalectomy	Active comparator	Laparoscopic Adrenalectomy Receives: Procedure: Laparoscopic Adrenalectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Morbidity rate
Measured: 30-day
Resolution of hyperaldosteronism
Measured: 1 year

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2017

First posted8 Jan 2014 (estimated)
Study startJan 2013
Primary completionDec 2016
Study completionDec 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HyperaldosteronismStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030587
Sponsor's protocol ID: CRE-2012.193-T
Acronym: LARFA
Status last verified: Apr 2017
First submitted: 5 Jan 2014
Last updated: 25 Apr 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 21107117

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
Recruiting
[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
Primary Aldosteronism
RecruitingPhase 2
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Hyperaldosteronism, Hypercortisolism
Recruiting
Comparing Inclisiran Versus Statin for Primary Aldosteronism
Primary Aldosteronism
Active, not recruitingPhase 3
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Primary Hyperaldosteronism

All Hyperaldosteronism trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02030587
Acronym / sponsor ID: LARFA / CRE-2012.193-T
Conditions: Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma
Keywords: Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: Jan 2013
Primary completion: Dec 2016 (actual)
Study completion: Dec 2017 (estimated)
First posted: 8 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Radiofrequency Ablation	Experimental	Procedure: Radiofrequency AblationRadiofrequency Ablation
Laparoscopic Adrenalectomy	Active comparator	Procedure: Laparoscopic AdrenalectomyLaparoscopic Adrenalectomy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Bilateral adrenal disease
Multiple adrenal tumors
Other concomitant adrenal diseases
Potentially malignant adrenal tumors as shown on imaging
Uncorrected coagulopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency Ablation	Procedure or surgery	Radiofrequency Ablation
Laparoscopic Adrenalectomy	Procedure or surgery	Laparoscopic Adrenalectomy

Primary outcome

Morbidity rate
Time frame: 30-day
Resolution of hyperaldosteronism
Time frame: 1 year

10 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Background: PubMed 21107117Liu 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.

Related trials for Hyperaldosteronism

RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
Recruiting
[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
Primary Aldosteronism
RecruitingPhase 2
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Hyperaldosteronism, Hypercortisolism
Recruiting
Comparing Inclisiran Versus Statin for Primary Aldosteronism
Primary Aldosteronism
Active, not recruitingPhase 3
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Primary Hyperaldosteronism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Enders KW Ng, MB ChB study chair

Chinese University of Hong Kong

Shirley YW Liu, MB ChB principal investigator

Chinese University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency Ablation and Laparoscopic Adrenalectomy in people with Hyperaldosteronism and Conn Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity rate (time frame: 30-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.