Partial Splenic Embolization Combined with Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate and Increases Recompensation Rate in Cirrhosis Patients with Hypersplenism: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The primary endpoint was variceal rebleeding
研究概览
简要总结
This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.
详细描述
Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.
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
- Single (Outcomes Assessor)
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).
- •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.
排除标准
- 未提供
结局指标
主要结局
The primary endpoint was variceal rebleeding
时间窗: 2 years
The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.
The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.
时间窗: 2 years
The hepatic recompensation rate based on Baveno VII criteria in the EP group will compared to that in the E group during the follow-up. Hepatic recompensation is a comprehensive assessment index defined as meeting all of the following criteria simultaneously: (1)Etiological Control: Removal/suppression/cure of the primary cause of cirrhosis (e.g., hepatitis C virus elimination, sustained suppression of hepatitis B virus, and sustained abstinence from alcohol in alcoholic cirrhosis); (2)Symptomatic Resolution: Regression of ascites (discontinuation of diuretics), remission of hepatic encephalopathy (discontinuation of lactulose/rifaximin), and absence of recurrent variceal bleeding (for at least 12 months); (3)Improvement in Liver Function: Stable improvement in liver function tests (albumin, INR, bilirubin). Assessed via lab tests (HCV RNA, HBV DNA, albumin, INR, bilirubin) and clinical evaluation (ascites, encephalopathy, endoscopy). Reported as binary (Yes/No).
次要结局
- Changes of the peripheral blood cell counts including white blood cell, red blood cell, and platelate counts in both group during 2-years follow up.(2 years)
- The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up(2 years)
- The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.(2 years)
研究者
Yanjing Gao
Vice presidengt of Department of Gastroenterology of Qilu Hospital
Qilu Hospital of Shandong University