Clinical Trial: Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial

Brief Summary: The purpose of this study is to determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Detailed Summary:

Background: Simple renal cysts are the most common renal masses, and occur in half of all patients older than 50 years.They are usually asymptomatic and benign, asymptomatic and discovered incidentally. However, over time, these simple cysts can enlarge, become symptomatic and develop complications, requiring intervention.They can be managed by a variety of surgical and percutaneous methods, including percutaneous aspiration (with or without injection of a sclerosing agent), endoscopic marsupialization or excision, open surgery and laparoscopic cyst excision.Percutaneous aspiration and sclerotherapy have been described as safe and effective methods of managing symptomatic simple renal cysts without the cost and morbidity associated with conventional surgery and laparoscopy.However, laparoscopic decortications and simple aspiration is associated with a high recurrence rate because the cyst wall epithelium is responsible for active liquid production.

Purpose:To determine whether microwave ablation is more effective in the treatment of simple renal cysts than conventional laparoscopic decortication.

Method:


Sponsor: RenJi Hospital

Current Primary Outcome: local recurrence [ Time Frame: 12 months postoperatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • postoperative complications [ Time Frame: postoperative，up to 30 days ]
  • operative time [ Time Frame: during operation ]
  • Hospital stay time [ Time Frame: time from the date of admission until the date of discharge, up to 2 weeks ]
  • quality of life assessed by quality of life questionnaire [ Time Frame: postoperative，up to 6 months ]
  • change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline [ Time Frame: baseline and 12 months ]


Original Secondary Outcome: Same as current

Information By: RenJi Hospital

Dates:
Date Received: February 18, 2017
Date Started: November 2016
Date Completion: November 2020
Last Updated: February 24, 2017
Last Verified: February 2017