A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- residual ratio of biliary stone
研究概览
简要总结
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.
详细描述
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 65 years old
- •Without gender restriction
- •With a favorable liver function of Child-Pugh A to B
- •No contraindications to surgery and anesthesia
- •Diagnosed with Hepatolithiasis and portal hypertension
- •Signed informed consent.
排除标准
- •Diffused type of Hepatolithiasis
- •Impairment in liver function
- •Severe disorders in vital organ
- •Accompanied with tumors.
结局指标
主要结局
residual ratio of biliary stone
时间窗: 3 months
residual ratio of biliary stone diagnosed within 3 months
次要结局
- mortality(3 months)
- residual lesions(6 months)
- postoperative complications(6 months)
- Health economics index(3 months)
研究者
feng xiaobin
Doctor
Southwest Hospital, China