Clinical Trial: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial

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.

Detailed Summary:
Sponsor: Chinese University of Hong Kong

Current Primary Outcome:

  • Morbidity rate [ Time Frame: 30-day ]
  • Resolution of hyperaldosteronism [ Time Frame: 1 year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: January 5, 2014
Date Started: January 2013
Date Completion: December 2017
Last Updated: April 22, 2017
Last Verified: April 2017