Long-term Efficacy and Safety of Laparoscopic Splenectomy and Azygoportal Disconnection Versus Transjugular Intrahepatic Portosystemic Shunt for Cirrhotic Portal Hypertension With Acute Esophagogastric Variceal Bleeding and Hypersplenism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- overall survival rate
研究概览
简要总结
This study aims to compare two treatments for cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism: laparoscopic splenectomy and azygoportal disconnection (LSD) and transjugular intrahepatic portosystemic shunt (TIPS). It is a single-center, prospective trial. The primary outcome is the incidence of post-procedure hepatic encephalopathy. Secondary outcomes include changes in hepatic venous pressure gradient, portal and hepatic artery hemodynamics, liver function, renal function, complete blood count, immune function, hepatic reserve capacity, serological markers of liver fibrosis, re-bleeding rate, hepatocellular carcinoma incidence, recompensation incidence, overall survival, and bleeding-free survival. The study will provide high-level evidence for optimal treatment selection in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cirrhotic portal hypertension.
- •Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment..
- •Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia.
- •Liver function Child-Pugh class A or B (score 7-9).
- •Age 18-75 years.
- •Patient provides written informed consent.
排除标准
- •Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score >
- •Severe right heart failure or pulmonary hypertension.
- •Uncontrolled systemic infection or sepsis.
- •Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation).
- •Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies.
- •Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.
- •Severe contrast agent allergy (affecting TIPS procedure).
- •Pregnancy or lactation.
- •Any severe non-hepatic disease with a life expectancy <1 year.
- •Recent gastric and duodenal ulcers.
- •Inability to comply with follow-up or provide informed consent.
研究组 & 干预措施
LSD
干预措施: LSD (Procedure)
TIPS
干预措施: TIPS (Procedure)
结局指标
主要结局
overall survival rate
时间窗: 5-year
overall survival rate
次要结局
未报告次要终点
研究者
Guo-Qing Jiang
Chief Physician
Northern Jiangsu People's Hospital