LARFA: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02030587
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

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

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Morbidity rate [30-day]

2. Resolution of hyperaldosteronism [1 year]

Secondary Outcome Measures

1. Operative time [24 hours]

2. Periprocedural hypertensive crisis [24 hours]

3. Mortality rate [30 days]

4. Blood loss [24 hours]

5. Analgesic requirement [30 days]

6. Time to resumption of activity [30 days]

7. Resolution of hypokalaemia [1 year]

8. Blood pressure control [1 year]

9. Hospital stay [30 days]

10. Pain score [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Shatin		Hong Kong

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

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.

• 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: Jan 8, 2014
• Last Update Posted: Apr 25, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Enders K.W. Ng, Professor, Chinese University of Hong Kong: Hyperaldosteronism; Adrenocortical adenoma; Adrenalectomy; Catheter ablation
• Additional relevant MeSH terms: Adenoma; Adrenocortical Adenoma; Hyperaldosteronism

Study Results

No Results Posted as of Apr 25, 2017