NCT02030587Unknown不适用
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Morbidity rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Hypertensive individuals
- •Biochemically confirmed primary aldosteronism
- •Radiologically confirmed unilateral adrenal adenoma ≤3cm
排除标准
- •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
研究组 & 干预措施
Radiofrequency Ablation
Experimental
Radiofrequency Ablation
干预措施: Radiofrequency Ablation (Procedure)
Laparoscopic Adrenalectomy
Active Comparator
Laparoscopic Adrenalectomy
干预措施: Laparoscopic Adrenalectomy (Procedure)
结局指标
主要结局
Morbidity rate
时间窗: 30-day
Resolution of hyperaldosteronism
时间窗: 1 year
次要结局
- Operative time(24 hours)
- Time to resumption of activity(30 days)
- Analgesic requirement(30 days)
- Periprocedural hypertensive crisis(24 hours)
- Hospital stay(30 days)
- Mortality rate(30 days)
- Blood loss(24 hours)
- Resolution of hypokalaemia(1 year)
- Blood pressure control(1 year)
- Pain score(7 days)
研究者
Enders K.W. Ng
Professor
Chinese University of Hong Kong
研究点 (1)
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