The Effects of Endoscopy Combined With Partial Splenic Artery Embolization in the Treatment of Cirrhosis With Esophageal and Gastric Varices Complicated With Hyperplenism or Splenomegaly:A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- rebleeding
研究概览
简要总结
The purpose of this study was to compare the effects of partial splenic artery embolization combined with endoscopic treatment and endoscopic treatment alone on portal hypertension in cirrhosis with hyperplenism or splenomegaly in esophageal and gastric varices.
详细描述
Although there have been many consensus opinions on the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage, there is no standard to follow for the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage combined with hypersplenism or splenomegalism, and studies show that the patients with cirrhosis combined with severe hypersplenism account for about 33%. It has been reported that partial splenic artery embolization is effective in the treatment of hypersplenism or splenomegaly caused by portal hypertension in liver cirrhosis, but for liver cirrhosis with esophageal and gastric varices hemorrhage in port or spleen large combined at the same time of endoscopic treatment should joint partial splenic artery embolization treatment remains controversial.Therefore, it is urgent to further study the effect of partial splenic artery embolization combined with endoscopic therapy on cirrhosis with esophageal and gastric variceal hemorrhage combined with hyperspleenism or splenomegaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years
- •Patients who had recovered from an episode of VH or patients who had survived from acute VH and there was no bleeding for consecutive 5 days
- •Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination
- •Patients with hypersplenism and thrombocytopenia (platelets < 100,000/µL).
排除标准
- •Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding
- •Bleeding from isolated gastric or ectopic varices
- •Hepatocellular carcinoma or other malignant tumors
- •Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40%
- •Hepatic failure
- •Contraindications for PSE
- •Pregnancy and lactation
- •Inability to sign the informed consent.
- •Primary prevention:
- •Inclusion Criteria:
- •Patients aged between 18 and 75 years
- •Moderate to severe esophageal (and/or) gastric varices
- •Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination
- •Patients with hypersplenism and thrombocytopenia (platelets < 100,000/µL).
- •Exclusion Criteria:
- •Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding
- •Bleeding from isolated gastric or ectopic varices
- •Hepatocellular carcinoma or other malignant tumors
- •Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40%
- •Hepatic failure
- •Contraindications for PSE
- •Pregnancy and lactation
- •Inability to sign the informed consent.
- •Acute bleeding:
- •Inclusion Criteria:
- •Patients aged between 18 and 75 years
- •Acute esophageal (and/or) gastric varices rupture and bleed <5 days
- •Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination
- •Patients with hypersplenism and thrombocytopenia (platelets < 100,000/µL).
- •Exclusion Criteria:
- •Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding
- •Bleeding from isolated gastric or ectopic varices
- •Hepatocellular carcinoma or other malignant tumors
- •Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40%
- •Hepatic failure
- •Contraindications for PSE
- •Pregnancy and lactation
- •Inability to sign the informed consent.
结局指标
主要结局
rebleeding
时间窗: 2 to 30days
the rate of rebleeding after endoscopic therapy
次要结局
未报告次要终点