Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal Lesions: Clinical Outcomes of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- local recurrence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with sporadic, unilateral, newly diagnosed Bosniak Ⅰ, Ⅱ and ⅡF renal cyst
- •patients agreeable to participate in this long-term follow-up study
- •patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
排除标准
- •patients' aged >80 years
- •patients not able to tolerate the microwave ablation procedure
- •patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
- •patients with the renal cyst involving urinary collecting system
- •patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
结局指标
主要结局
local recurrence
时间窗: 12 months postoperatively
次要结局
- operative time(during operation)
- quality of life assessed by quality of life questionnaire(postoperative，up to 6 months)
- postoperative complications(postoperative，up to 30 days)
- change from baseline glomerular filtration rate (GFR) of the affected kidney, 12 months minus baseline(baseline and 12 months)
- Hospital stay time(time from the date of admission until the date of discharge, up to 2 weeks)