The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Humoral Immune Markers from Baseline to 6 Months Postoperation
研究概览
简要总结
In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.
详细描述
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.
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 —（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
- •gastroesophageal variceal bleeding
- •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
- •Human immunodeficiency virus (HIV) infection
结局指标
主要结局
Change in Humoral Immune Markers from Baseline to 6 Months Postoperation
时间窗: Baseline (preoperative) and 6 months postoperation
Serum levels of immunoglobulins (IgG, IgA, IgM), complement proteins (C3, C4), and B-cell markers (CD19, CD20) will be measured. The primary outcome is the change in these markers from preoperative baseline to 6 months after surgery.
Platelet Count at 6 Months Postoperation
时间窗: 6 months postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Hemoglobin Level at 6 Months Postoperation
时间窗: 6 months postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Blood Flow Velocity of the Portal Vein at 6 Months Postoperation
时间窗: 6 months postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
White Blood Cell Count at 6 Months Postoperation
时间窗: 6 months postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Vascular Diameter of the Portal Vein at 6 Months Postoperation
时间窗: 6 months postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation
时间窗: 6 months postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation
时间窗: 6 months postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Vascular Diameter of the Splenic Vein at 6 Months Postoperation
时间窗: 6 months postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Incidence of Portal Venous System Thrombosis within 6 Months Postoperation
时间窗: 6 months postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
次要结局
- Comparison of Humoral Immune Marker Levels at 7 Days Postoperation(7 days postoperation)
- Comparison of Humoral Immune Marker Levels at 3 months Postoperation(3 months postoperation)
- Platelet Count at 3 Months Postoperation(3 months postoperation)
- Platelet Count at 12 Months Postoperation(12 months postoperation)
- White Blood Cell Count at 3 Months Postoperation(3 months postoperation)
- Platelet Count at 1 Month Postoperation(1 month postoperation)
- Comparison of Humoral Immune Marker Levels at 1 Month Postoperation(1 month postoperation)
- Comparison of Humoral Immune Marker Levels at 12 Months Postoperation(12 Months postoperation)
- Vascular Diameter of the Portal Vein at 12 Months Postoperation(12 months postoperation)
- White Blood Cell Count at 1 Month Postoperation(1 month postoperation)
- White Blood Cell Count at 12 Months Postoperation(12 months postoperation)
- Hemoglobin Level at 1 Month Postoperation(1 month postoperation)
- Hemoglobin Level at 3 Months Postoperation(3 months postoperation)
- Hemoglobin Level at 12 Months Postoperation(12 months postoperation)
- Blood Flow Velocity of the Portal Vein at 3 Months Postoperation(3 months postoperation)
- Blood Flow Velocity of the Portal Vein at 12 Months Postoperation(12 months postoperation)
- Vascular Diameter of the Portal Vein at 3 Months Postoperation(3 months postoperation)
- Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation(3 months postoperation)
- Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation(12 months postoperation)
- Vascular Diameter of the Splenic Vein at 3 Months Postoperation(3 months postoperation)
- Vascular Diameter of the Splenic Vein at 12 Months Postoperation(12 months postoperation)
- Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation(3 months postoperation)
- Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation(9 months postoperation)
- Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation(12 months postoperation)
- Incidence of Portal Venous System Thrombosis within 12 Months Postoperation(12 months postoperation)
- Incidence of Postoperative Complications within 30 Days(30 days postoperation)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital