NCT02030587

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. 1.compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma.
  2. 2.compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 5, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

January 5, 2014

Last Update Submit

April 22, 2017

Conditions

HyperaldosteronismConn SyndromeAdrenocortical Adenoma

Keywords

HyperaldosteronismAdrenocortical adenomaAdrenalectomyCatheter ablation

Outcome Measures

Primary Outcomes (2)

  • Morbidity rate

    30-day

  • Resolution of hyperaldosteronism

    1 year

Secondary Outcomes (10)

  • Operative time

    24 hours

  • Periprocedural hypertensive crisis

    24 hours

  • Mortality rate

    30 days

  • Blood loss

    24 hours

  • Analgesic requirement

    30 days

  • +5 more secondary outcomes

Study Arms (2)

Radiofrequency Ablation

EXPERIMENTAL

Radiofrequency Ablation

Procedure: Radiofrequency Ablation

Laparoscopic Adrenalectomy

ACTIVE COMPARATOR

Laparoscopic Adrenalectomy

Procedure: Laparoscopic Adrenalectomy

Interventions

Radiofrequency AblationPROCEDURE
Radiofrequency Ablation
Laparoscopic AdrenalectomyPROCEDURE
Laparoscopic Adrenalectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 21107117BACKGROUND

MeSH Terms

Conditions

HyperaldosteronismAdrenocortical Adenoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Enders KW Ng, MB ChB

    Chinese University of Hong Kong

    STUDY CHAIR

  • Shirley YW Liu, MB ChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2014

First Posted

January 8, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

HK(1)