Laparoscopic Adrenalectomy Versus Radiofrequency Ablation | NCT02030587

Studies
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

NCT02030587

Sponsor

Chinese University of Hong Kong

Status

Unknown status

Last Update Posted

Apr 25, 2017Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Hyperaldosteronism
Conn Syndrome
Adrenocortical Adenoma

Interventions

Radiofrequency Ablation
Laparoscopic Adrenalectomy

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 5, 2014

First Submission Date that Met QC Criteria

Jan 7, 2014

First Posted Date

Jan 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2017

Last Update Posted Date

Apr 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Enders K.W. Ng, Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiofrequency Ablation	Experimental	Radiofrequency Ablation	Procedure: Radiofrequency Ablation
Laparoscopic Adrenalectomy	Active Comparator	Laparoscopic Adrenalectomy	Procedure: Laparoscopic Adrenalectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency Ablation	Procedure		Radiofrequency Ablation
Laparoscopic Adrenalectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Operative time		24 hours
Periprocedural hypertensive crisis		24 hours
Mortality rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enders KW Ng, MB ChB	Chinese University of Hong Kong	Study Chair
Shirley YW Liu, MB ChB	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Shatin			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21107117	Background	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.

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D000306	Adrenal Cortex Neoplasms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

ID	Term
D006929	Hyperaldosteronism
D018246	Adrenocortical Adenoma