Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

NCT ID: NCT02030587

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperaldosteronism Conn Syndrome Adrenocortical Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency Ablation

Radiofrequency Ablation

Group Type EXPERIMENTAL

Radiofrequency Ablation

Intervention Type PROCEDURE

Laparoscopic Adrenalectomy

Laparoscopic Adrenalectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic Adrenalectomy

Intervention Type PROCEDURE

Interventions

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Radiofrequency Ablation

Intervention Type PROCEDURE

Laparoscopic Adrenalectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Enders K.W. Ng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enders KW Ng, MB ChB

Role: STUDY_CHAIR

Chinese University of Hong Kong

Shirley YW Liu, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 21107117 (View on PubMed)

Other Identifiers

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CRE-2012.193-T

Identifier Type: -

Identifier Source: org_study_id

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