Laparoscopic Adrenalectomy Versus Radiofrequency Ablation (LARFA)

April 22, 2017 updated by: Enders K.W. Ng, Chinese University of Hong Kong

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency Ablation
Procedure: Radiofrequency Ablation
Active Comparator: Laparoscopic Adrenalectomy
Procedure: Laparoscopic Adrenalectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity rate
Time Frame: 30-day
30-day
Resolution of hyperaldosteronism
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Study Chair: Enders KW Ng, MB ChB, Chinese University of Hong Kong
  • Principal Investigator: Shirley YW Liu, MB ChB, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 5, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2012.193-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperaldosteronism

Clinical Trials on Radiofrequency Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe