The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Liver reserve function ICG-K level at 12 months after surgery
研究概览
简要总结
In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.
详细描述
The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh, ascites, prealbumin, ICG-K, ICG-R 15 and ICG-T/2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- •Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L
- •Informed consent to participate in the study
排除标准
- •Hepatocellular carcinoma or any other malignancy,
- •Child-Pugh grade C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Pregnancy.
- •Uncontrolled Hypertension
- •Bleeding portal hypertension
- •Human immunodeficiency virus (HIV) infection
结局指标
主要结局
Liver reserve function ICG-K level at 12 months after surgery
时间窗: 12 months
The level of liver reserve function ICG-K level at 12 months after surgery.
Liver reserve function ICG-R15 level at 3 months after surgery.
时间窗: 3 months
The level of liver reserve function ICG-R15 level at 3 months after surgery.
Liver reserve function ICG-R15 level at 24 months after surgery.
时间窗: 24 months
The level of liver reserve function ICG-R15 level at 24 months after surgery.
Liver reserve function ICG-T/2 level at 12 months after surgery.
时间窗: 12 months
The level of liver reserve function ICG-T/2 level at 12 months after surgery.
Liver reserve function ICG-K level at 3 months after surgery
时间窗: 3 months
The level of liver reserve function ICG-K level at 3 months after surgery.
Liver reserve function ICG-K level at 6 months after surgery.
时间窗: 6 months
The level of liver reserve function ICG-K level at 6 months after surgery.
Liver reserve function ICG-K level at 24 months after surgery.
时间窗: 24 months
The level of liver reserve function ICG-K level at 24 months after surgery.
Liver reserve function ICG-R15 level at 6 months after surgery.
时间窗: 6 months
The level of liver reserve function ICG-R15 level at 6 months after surgery.
Liver reserve function ICG-T/2 level at 3 months after surgery.
时间窗: 3 months
The level of liver reserve function ICG-T/2 level at 3 months after surgery.
Liver reserve function ICG-T/2 level at 6 months after surgery.
时间窗: 6 months
The level of liver reserve function ICG-T/2 level at 6 months after surgery.
Liver reserve function ICG-T/2 level at 24 months after surgery.
时间窗: 24 months
The level of liver reserve function ICG-T/2 level at 24 months after surgery.
Liver reserve function ICG-R15 level at 12 months after surgery.
时间窗: 12 months
The level of liver reserve function ICG-R15 level at 12 months after surgery.
次要结局
未报告次要终点
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital